{"source":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters","urlPrefix":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/","fetched":"2026-11-06","scope":"Letters issued by CDER, CDRH and CBER. Tobacco, food and veterinary letters are excluded.","offices":["CDER","CBER","CDRH"],"products":["Drugs","Biologics Drugs Food & Beverages","Medical Devices","Unspecified","Biologics","Biologics Drugs","Drugs Over-the-Counter Drugs","Biologics Dietary Supplements Drugs","Animal & Veterinary Drugs","Drugs Food & Beverages","Biologics Medical Devices","Animal & Veterinary Drugs Food & Beverages","Drugs Medical Devices","Dietary Supplements Drugs","Cosmetics Drugs","Food & Beverages","Tobacco","Biologics Food & Beverages","Medical Devices Ear, Nose & Throat","Medical Devices Premarket Approval (PMA)","Medical Devices UDI","Biologics Good Clinical Practice (GCP)","Drugs Pharmaceutical Quality"],"tags":["Data integrity","Aseptic processing","Sterility assurance","Cleaning validation","Process validation","Method validation","Stability","Out-of-specification","Environmental monitoring","CAPA","Complaint handling","MDR reporting","Design controls","Supplier controls","Quality unit","Batch records","Unapproved new drug","Misbranded","Adulterated","Marketing claims","510(k) required","Labeling"],"boilerplateTags":["Misbranded","Adulterated"],"letters":[["2026-10-30","RonanRx, Inc. dba RonanRx",0,0,"","","ronanrx-inc-dba-ronanrx-737905-10302026","",0,[16,17],"3048890334","",""],["2026-10-29","Conroe Welding Supply, Inc.",0,0,"","Mr. Ricky Morton","conroe-welding-supply-inc-731507-10292026","",0,[7,10,11,13,14,18],"1625647","",""],["2026-10-27","Guangdong Bisutang Biotechnology Co., Ltd.",0,0,"","Mr. Jianfang Chen","guangdong-bisutang-biotechnology-co-ltd-733939-10272026","",0,[17,18],"3031796296","",""],["2026-10-27","Guangzhou Jiugong Research And Development Biotechnology Co., Ltd.",0,6,"","Mr. Yun Ma","guangzhou-jiugong-research-and-development-biotechnology-co-ltd-737769-10272026","",0,[14,17,18],"3043646847","",""],["2026-10-27","Pritam International Private Limited",0,6,"","Dr. Rahul Mahajan Sr","pritam-international-private-limited-738079-10272026","",0,[0,13,14,15,18],"3020826443","",""],["2026-10-26","Bella\u2019s Nutri Shop Inc.",0,0,"","","bellas-nutri-shop-inc-737491-10262026","",0,[16,17,21],"3018073774","",""],["2026-10-26","Guangdong Bangze Medicine Co., Ltd.",0,6,"","Mr. Yongliang Fang","guangdong-bangze-medicine-co-ltd-734509-10262026","",0,[6,14,18],"3035364398","",""],["2026-10-26","Jing Cheong Asia Inc. dba New York Tong Ren Tang",0,0,"","Timothy Chuang","jing-cheong-asia-inc-dba-new-york-tong-ren-tang-738200-10262026","",0,[16],"3003808101","",""],["2026-10-26","Natuzem",0,0,"","","natuzem-737558-10262026","",0,[16],"3027756675","",""],["2026-10-26","New Green Nutrition Inc.",0,0,"","Peng Xiang Lu","new-green-nutrition-inc-737576-10262026","",0,[16,17,21],"3033137355","",""],["2026-10-26","Ong Tien USA LLC",0,0,"","","ong-tien-usa-llc-737352-10262026","",0,[16,17,21],"3030356170","",""],["2026-10-26","Phuoc Loc Tho Herbals, Inc.",0,0,"","Quang Chi Dinh","phuoc-loc-tho-herbals-inc-736860-10262026","",0,[16],"3032319226","",""],["2026-10-23","Best Chinese Medicines LLC",0,0,"","Gretchen Synclaire","best-chinese-medicines-llc-738556-10232026","",0,[16],"3049383453","",""],["2026-10-22","Northland Nuclear Medicine, LLC",0,0,"","Nathan J. Fleck, Pharm.D.","northland-nuclear-medicine-llc-736893-10222026","",0,[1,2,8,14,18],"3005334016","",""],["2026-10-22","Sanrace Biotechnology Co., Ltd.",0,6,"","Mr. Qi-Lian He General Manager","sanrace-biotechnology-co-ltd-737549-10222026","",0,[4,6,13,14,18],"3016897521","",""],["2026-10-22","TSP Solutions Pte. Ltd.",0,6,"","Mr. Min-tsek Lau","tsp-solutions-pte-ltd-735071-10222026","",0,[6,13,14,15,18],"3023093622","",""],["2026-10-14","Rohto Pharmaceutical Co., Ltd.",0,6,"","Mr. Kunio Yamada","rohto-pharmaceutical-co-ltd-733215-10142026","",0,[0,1,2,8,14,15,16,17,18],"3008808745","",""],["2026-10-13","Calibrate IV Hydration",1,4,"","Neville Campbell, MD","calibrate-iv-hydration-729846-10132026","The United States Food and Drug Administration (FDA) reviewed your company\u2019s website at https://www.calibrateiv.com/ (last visited October 2026), through which your company sells umbilical cord derived and exosome 1 products for allogeneic use (collectively, \u201c",0,[16,19],"3044733959","",""],["2026-10-08","Microspecialties, LLC",2,2,"","Gaston S. Levesque","microspecialties-llc-707614-10082026","The Food and Drug Administration has completed evaluation of your firm\u2019s corrective actions in response to our Warning Letter # 707614, dated May 8, 2025. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Le",0,[],"3002616700","",""],["2026-10-07","Olympus Medical Systems Corporation",2,2,"","","olympus-medical-systems-corporation-729208-10072026","The United States Food and Drug Administration (FDA) conducted the following inspections of your firm\u2019s medical device facilities: Olympus Medical Systems Corporation, located at 2951 Ishikawa-Cho, Hachioji-Shi, Tokyo, JP 192-8507, FEI 3002807795, November 17,",0,[7,11,12,18],"3011050570","",""],["2026-10-06","Eurofins SF Analytical Laboratories, Inc.",0,0,"","Mr. David Riggs","eurofins-sf-analytical-laboratories-inc-736056-10062026","",0,[0,7,14,18],"3014704316","",""],["2026-10-06","Lovelace Biomedical Research Institute",0,0,"","Robert W. Rubin","lovelace-biomedical-research-institute-725136-10062026","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at Lovelace Biomedical Research Institute (LBRI) between April 7 and 18, 2025. The investigator representing FDA review",0,[9],"","",""],["2026-10-06","Tides Medical LLC",1,4,"","Joe Spell","tides-medical-llc-727246-10062026","The United States Food and Drug Administration (FDA) has learned that your firm is distributing APLICOR 3D in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act). Under section 201(h) of",0,[17,18,20],"3012622594","",""],["2026-10-05","Pro-Optics, LLC",2,2,"","Eric A. Nyman","pro-optics-llc-734689-10052026","During an inspection of your firm located in Palatine, Illinois from March 3, 2026 through March 11, 2026, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Tight Top Contact Lens Cases and Flip To",0,[17,18,20],"1419844","",""],["2026-10-05","Silgan Dispensing Systems",0,6,"","Mr. Earl Lawson","silgan-dispensing-systems-734538-10052026","",0,[2,3,6,7,8,14,16,18],"3011913386","",""],["2026-10-02","Chirp Innovations, LLC",2,2,"","Tate S. Stock","chirp-innovations-llc-731847-10022026","During an inspection of your firm located in Lehi, Utah from November 18, 2025, through November 21, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures an Over-The-Counter Transcutaneous Nerve",0,[9,10,11,12,13,17,18,20],"3020769982","",""],["2026-10-02","Hanlim Pharm Co., Ltd.",0,0,"","Mr. Jungjin Kim","hanlim-pharm-co-ltd-734782-10022026","",0,[1,2,6,8,14,18],"3004886113","",""],["2026-10-01","Aidance Scientific, Inc.",0,6,"","Perry Antelman","aidance-scientific-inc-735346-10012026","",0,[16,17,18],"3006613129","",""],["2026-10-01","Amazon.com, Inc.",0,6,"","Andy Jassy","amazoncom-inc-736006-10012026","",0,[16,17,18],"3016994737","",""],["2026-10-01","Bioactive Services USA, LLC / Herstat Inc.",0,6,"","Kevin Aspinall Nessling","bioactive-services-usa-llc-herstat-inc-734784-10012026","",0,[16],"3017843679","",""],["2026-10-01","DesBio/Deseret Biologicals, Inc.",0,6,"","Jake Carter","desbiodeseret-biologicals-inc-735464-10012026","",0,[16,17,18],"3002514104","",""],["2026-10-01","Graceful Touch, LLC",0,6,"","Guy Siverson","graceful-touch-llc-735272-10012026","",0,[16],"3047109748","",""],["2026-10-01","OrganiCare, LLC / OrganiCare Nature\u2019s Science, LLC",0,6,"","Caroline Goodner","organicare-llc-organicare-natures-science-llc-734925-10012026","",0,[16,17,18],"3013202192","",""],["2026-10-01","The Platinum Healthcare LLC",0,6,"","Jamey Hagan","platinum-healthcare-llc-735147-10012026","",0,[16,17,18],"3046965559","",""],["2026-10-01","RoyceDerm LLC",0,6,"","","roycederm-llc-734781-10012026","",0,[16],"3027092526","",""],["2026-10-01","Signature Formulations LLC",0,0,"","Maria C. Esparza","signature-formulations-llc-737964-10012026","",0,[3,14,18],"3011368010","",""],["2026-10-01","Terramed",0,6,"","Krystsina Uradzimskaya","terramed-735070-10012026","",0,[16,17,18],"3046910637","",""],["2026-10-01","Walmart, Inc.",0,6,"","John Furner","walmart-inc-736557-10012026","",0,[16,17,18],"2316750","",""],["2026-10-01","Zhejiang Gaorong Cosmetic Co., Ltd.",0,6,"","Ms. Yunji (Lucy) Gao","zhejiang-gaorong-cosmetic-co-ltd-732511-10012026","",0,[6,13,14,17,18],"3009819718","",""],["2026-09-29","Baxter International Inc.",0,0,"","Mr. Andrew Hider","baxter-international-inc-733231-09292026","",0,[1,2,3,8,14,18],"1416980","",""],["2026-09-28","SnugZ USA, Inc.",0,6,"","Mr. Brandon K. Mackay","snugz-usa-inc-735284-09282026","",0,[0,6,7,10,13,14,15,18],"3009188709","",""],["2026-09-25","Beaute Bounty",1,4,"","","beaute-bounty-729163-09252026","",0,[16,19],"3044450025","",""],["2026-09-24","Cheap Medicine Shop/www.cheapmedicineshop.com",0,0,"","","cheap-medicine-shopwwwcheapmedicineshopcom-737810-09242026","",0,[16,17,21],"","",""],["2026-09-23","Glenmark Pharmaceuticals Limited",0,0,"","Mr. Ganpat Sonybapu Pote","glenmark-pharmaceuticals-limited-637314-09232026","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-23-04 dated November 22, 2022. Based on our evaluation, it appears that you have addressed the violations contained in th",0,[],"3004672766","",""],["2026-09-23","Jiangmen Shuizirun Sanitary Articles Co., Ltd.",0,6,"","Mr. Huashen Liang","jiangmen-shuizirun-sanitary-articles-co-ltd-722974-09232026","",0,[2,13,14,18],"3014159182","",""],["2026-09-23","Online Generic Medicine/www.onlinegenericmedicine.com",0,0,"","","online-generic-medicinewwwonlinegenericmedicinecom-737806-09232026","",0,[16,17,21],"","",""],["2026-09-22","Fresenius Kabi USA LLC",0,0,"","Mr. Pierluigi Antonelli","fresenius-kabi-usa-llc-733107-09222026","",0,[1,2,7,8,13,14,15,18],"","",""],["2026-09-22","Unilam Co., LTD",2,2,"","Joo-Young Yoon","unilam-co-ltd-738562-09222026","",0,[12,13,18,20],"","",""],["2026-09-21","Babikian Healthcare Products CJSC",0,6,"","Dr. Dikran Babikian","babikian-healthcare-products-cjsc-730513-09212026","",0,[6,13,14,15,17,18],"3027526825","",""],["2026-09-18","Curia New York, Inc.",0,0,"","Philip Macnabb","curia-new-york-inc-728790-09182026","",0,[0,6,14,18],"1310298","",""],["2026-09-18","Empower Clinic Services, LLC dba Empower Pharmacy",0,0,"","Arta Shaun Noorian","empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026","From November 3, 2025, through November 14, 2025, U.S. Food and Drug Administration (FDA) investigators inspected your facility, Empower Clinic Services, LLC dba Empower Pharmacy, located at 7601 N. Sam Houston Pkwy W., Ste. 100, Houston, TX 77064. During the",0,[0,1,2,14,16,17,18,21],"3021758709","",""],["2026-09-18","Zenzi Pharmaceutical Industries Private Limited",0,0,"","Jacob Sporon-Fiedler","zenzi-pharmaceutical-industries-private-limited-701130-09182026","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s responses to our Warning Letter 320-25-45 dated February 13, 2025, and our subsequent 704(a)(4) request for records issued on May 22, 2026. Based on our evaluation, it appears th",0,[18],"3032916295","",""],["2026-09-17","Bentley Laboratories LLC",0,6,"","Mr. James Burke","bentley-laboratories-llc-732028-09172026","",0,[3,4,7,13,14,16,17,18],"2244819","",""],["2026-09-14","Celmade",0,0,"","","celmade-735876-09142026","",0,[16,17,21],"","",""],["2026-09-14","SCA Pharmaceuticals, LLC",0,0,"","Kenneth P. Bonnell","sca-pharmaceuticals-llc-724202-09142026","You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. \u00a7 353b] 1 on December 13, 2013, and most recently on December 5, 2025. Fro",0,[1,2,8,14,17,18,21],"3010683157","",""],["2026-09-11","NexCell Scientific Inc",1,4,"","Edwin Pinos","nexcell-scientific-inc-730612-09112026","The United States Food and Drug Administration (FDA) inspected your facility, located at the above address, between December 9 and 12, 2025, and between February 3 and 5, 2026. During the inspection, FDA documented that your company manufactures an umbilical c",0,[1,2,8,14,16,18,19],"3015826052","",""],["2026-09-08","kdc/one Chatsworth, Inc.",0,6,"","Mr. Peter F. Rawson","kdcone-chatsworth-inc-733205-09082026","",0,[6,7,14,17,18],"","",""],["2026-09-04","Bausch & Lomb Inc.",0,6,"","Mr. Robert T. Fulop","bausch-lomb-inc-732398-09042026","",0,[1,2,8,14,18],"1000113778","",""],["2026-09-02","TCI Co., Ltd BioCosme PABP BRANCH",0,6,"","Vincent Lin","tci-co-ltd-biocosme-pabp-branch-736888-09022026","",0,[3,4,14,15,18],"","",""],["2026-09-01","O.N. Diagnostics, LLC",2,2,"","Shui Wong","diagnostics-llc-730301-09012026","",0,[11,13,17,18,20],"3010687441","",""],["2026-09-01","Happy Farm Botanicals, Inc.",0,6,"","Mr. Hamed Alaghebandian","happy-farm-botanicals-inc-731926-09012026","",0,[3,4,6,13,14,17,18],"3011407349","",""],["2026-08-27","Jabil Inc.",0,0,"","Mr. Michael Dastoor","jabil-inc-731037-08272026","",0,[1,2,3,4,6,7,8,14,15,18],"3006503102","",""],["2026-08-27","Stephen J. Fallon, Ph.D.",1,4,"","","stephen-j-fallon-phd-728673-08272026","This Warning Letter informs you of objectionable conditions observed during a U.S. Food and Drug Administration (FDA) inspection conducted at your clinical study site between June 2, 2025, and June 13, 2025. The FDA Investigators met with you during the inspec",0,[],"3014441387","",""],["2026-08-26","Peter Schiff Enterprises",2,2,"","Peter Schiff","peter-schiff-enterprises-727888-08262026","",0,[2,9,10,11,12,13,17,18,20],"1000112898","",""],["2026-08-25","Advance-Esthetic LLC",2,2,"","Kostiantyn Suichmez","advance-esthetic-llc-729267-08252026","During an inspection of your firm located in Fort Lauderdale, Florida from October 27, 2025, through November 6, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures and markets Zemits CrystalFr",0,[17,18,20],"3013397886","",""],["2026-08-25","Fresenius Medical Care AG & Co. KGaA",0,0,"","Ms. Helen Giza","fresenius-medical-care-ag-co-kgaa-730319-08252026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Fresenius USA Manufacturing, Inc. dba Fresenius Medical Care North America Ogden Plant, FEI 1713747, at 475 W. 13th St., Ogden, Utah, from March 2 to 6, 2026. This",0,[2,4,7,10,14,18],"1713747","",""],["2026-08-24","Jiangsu Caina Medical Co. Ltd.",2,2,"","Jun Lu","jiangsu-caina-medical-co-ltd-687033-08242026","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter CMS#687033 issued July 18, 2024. Based on our evaluation, it appears that you have addressed the violations contained in this",0,[],"3005670221","",""],["2026-08-24","Soulaire Corporation",2,2,"","Morad Soulati","soulaire-corporation-675069-08242026","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 675069, dated January 29, 2024). Based on our evaluation, it appears that you have addressed the violation(s) contained in t",0,[],"3017791225","",""],["2026-08-24","NuScience Peptides LLC",0,0,"","Joseph and Ratsamy DeRosa","nuscience-peptides-llc-733652-08242026","",0,[16],"3035645456","",""],["2026-08-24","Peak Performance Peptides",0,0,"","Jeffrey Deng","peak-performance-peptides-735127-08242026","",0,[16],"3046962858","",""],["2026-08-24","Peptide Partners LLC",0,0,"","Zachary David Hoff","peptide-partners-llc-735063-08242026","",0,[16],"3046663644","",""],["2026-08-24","Royal Peptides LLC",0,0,"","Rocco Abate and Michael Fraunfelter","royal-peptides-llc-734884-08242026","",0,[16],"3046869390","",""],["2026-08-24","TXP Innovations LLC dba Tex Peptides",0,0,"","Felicia Romero","txp-innovations-llc-dba-tex-peptides-735067-08242026","",0,[16],"3046662843","",""],["2026-08-21","Lion Street Medical, d/b/a Pensar Medical LLC",2,2,"","Jason Allen Bandy","lion-street-medical-dba-pensar-medical-llc-733015-08212026","During an inspection of your firm located in Houston, TX from April 14, 2026, through April 28, 2026, an investigator from the United States Food and Drug Administration (FDA) determined that your firm, Lion Street Medical, d/b/a Pensar Medical LLC, manufactur",0,[2,9,10,11,15,17,18,19,20],"3007793449","",""],["2026-08-19","Next Medical Products Company, LLC",2,2,"","Ms. Julia M. Jacobson","next-medical-products-company-llc-727918-08192026","During an inspection of your firm located in Branchburg, NJ from November 10, 2025 through December 10, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Clear Image Ultrasound Gel, Clear Ima",0,[2,8,9,11,17,18,20,21],"2523891","",""],["2026-08-18","PReye, LLC",0,0,"","Dr. Melinda C. O\u2019Rourke","preye-llc-732141-08182026","",0,[1,2,13,14,16,18],"3031057987","",""],["2026-08-18","Reliance Life Sciences Private Limited",0,0,"","Mr. Santhosh Mathai","reliance-life-sciences-private-limited-730801-08182026","",0,[0,1,2,6,8,14,18],"3009510975","",""],["2026-08-18","Shoolin Pharma Chem LLP",0,0,"","Dr. Santosh R. Patel and Mr. Rajendra C. Patel","shoolin-pharma-chem-llp-734100-08182026","",0,[0,2,3,6,7,14,18],"3038200383","",""],["2026-08-14","R3 Medical Companies",1,4,"","David L. Greene, M.D.","r3-medical-companies-726330-08142026","The United States Food and Drug Administration (FDA) inspected your facilities, Bello Bio, LLC (herein referred to as \u201cBello\u201d) and Regen Suppliers, LLC (herein referred to as \u201cRegen\u201d) co-located at 10045 E. Dynamite Blvd., Suite 260, Scottsdale, AZ 85262, betw",0,[1,2,14,16,18,19],"3015273117","",""],["2026-08-13","Eugia Pharma Specialities Limited",0,0,"","Mr. Yugandhar Puvvala","eugia-pharma-specialities-limited-730469-08132026","",0,[1,2,8,14,18],"3011960448","",""],["2026-08-13","Suretec Innovations, LLC",0,6,"","Mr. Travis Brady","suretec-innovations-llc-730122-08132026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Suretec Innovations, LLC, FEI 3030456591, at 190 South McQueen Road, Suite 102, Gilbert, Arizona, from March 2 to 5, 2026. This warning letter summarizes significa",0,[13,14,17,18],"3030456591","",""],["2026-08-12","Auriga Research Pvt. Ltd.",0,0,"","Dr. Saurabh Arora","auriga-research-pvt-ltd-730694-08122026","",0,[0,7,14,18],"3019975128","",""],["2026-08-12","K.C. Pharmaceuticals, Inc.",0,6,"","Ms. Ratnawati Li","kc-pharmaceuticals-inc-729870-08122026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, K.C. Pharmaceuticals, Inc., FEI 2026940, at 3420 Pomona Blvd., Pomona, CA, from January 20 to February 13, 2026. This warning letter summarizes significant violati",0,[1,2,5,6,8,9,14,18],"2026940","",""],["2026-08-07","Safrel Pharmaceuticals LLC",0,6,"","Mr. Dipen Patel","safrel-pharmaceuticals-llc-730520-08072026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Safrel Pharmaceuticals LLC, FEI 3042030663, at 178 Ridge Road, Dayton, New Jersey, from January 13 to January 30, 2026. This Warning Letter summarizes significant",0,[13,14,18],"","",""],["2026-08-07","Pine Pharmaceuticals, LLC",0,0,"","Alfonse J. Muto PharmD","pine-pharmaceuticals-llc-728537-08072026","You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. \u00a7 353b] 1 on March 9, 2018, and most recently on November 19, 2025. From N",0,[1,2,3,4,8,10,14,15,17,18,21],"3010943533","",""],["2026-08-06","Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd.",0,0,"","Wenjun Liao","tianjin-kilo-pharmaceutical-sci-tech-co-ltd-731761-08062026","",0,[4,5,6,15,17,18],"","",""],["2026-07-31","FairyGene, Inc.",0,0,"","Mr. Yong Liu","fairygene-inc-726976-07312026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, FairyGene, Inc., FEI 3023594691, at 2 Pearl Buck Court, Suite 1, Bristol, from January 12 to 15, 2026. This warning letter summarizes significant violations of Cur",0,[2,3,4,6,14,15,16,17,18],"3023594691","",""],["2026-07-30","Global Calcium House 1",0,0,"","Mr. Sahil Vaz","global-calcium-house-1-692000-07302026","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-25-30 dated January 16, 2025. Based on our evaluation, it appears that you have addressed the deviations contained in thi",0,[],"3004094136","",""],["2026-07-30","Lico Industries, LLC., d.b.a. American Towelette Company",0,0,"","Ms. Maggan A. Lively","lico-industries-llc-dba-american-towelette-company-729921-07302026","",0,[0,3,7,14,15,18],"3003411169","",""],["2026-07-29","Similasan AG",0,0,"","Dr. Urs Lehmann","similasan-ag-658878-07292026","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 658878, dated September 11, 2023. Based on our evaluation, it appears that you have addressed the violations contained in thi",0,[],"1000110034","",""],["2026-07-27","Maria E. De La Torre Silva, M.D.",0,0,"","","maria-e-de-la-torre-silva-md-735690-07272026","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between June 26 and July 15, 2025. The investigators representing FDA reviewed your conduct of th",0,[],"3038474315","",""],["2026-07-27","MedisourceRx",0,0,"","Daniel D. Hernandez","medisourcerx-717970-07272026","The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our warning letter #717970, issued on December 12, 2025. Based on our evaluation, it appears that you have adequately addressed the violati",0,[],"3013316698","",""],["2026-07-27","Nubratori, Inc. dba Nubratori Rx",0,0,"","Robert P. Nickell","nubratori-inc-dba-nubratori-rx-700513-07272026","The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our warning letter #700513, issued on January 22, 2025 Based on our evaluation, it appears that you have adequately addressed the violation",0,[],"3010166491","",""],["2026-07-27","Thrive Health and Wellness, LLC dba Thrive Health Solutions",0,0,"","Doug Hatch","thrive-health-and-wellness-llc-dba-thrive-health-solutions-714891-07272026","The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our warning letter #714891, issued on February 9, 2026. Based on our evaluation, it appears that you have adequately addressed the violatio",0,[],"3033176989","",""],["2026-07-27","Woodbine Products Company Inc.",0,6,"","Mr. Stephen A. Kuzyk Jr.","woodbine-products-company-inc-729345-07272026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Woodbine Products Company Inc., FEI 1519202, at 915 W. Smith Road, Medina, from February 9 to 13, 2026. This warning letter summarizes significant violations of Cu",0,[3,4,13,14,17,18],"1519202","",""],["2026-07-24","Dabur India Limited",0,6,"","Mr. Mohit Malhotra","dabur-india-limited-728828-07242026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Dabur India Limited, FEI 3001413302, at Survey No. 225/4/1, Village: Saily, Silvassa, Dadra and Nagar Haveli and Daman and Diu, from January 12 to 16, 2026. This w",0,[0,3,4,6,7,14,18],"3001413302","",""],["2026-07-24","Nipro Renal Solutions USA, Corporation",2,20,"","Tsuyoshi Yamazaki","nipro-renal-solutions-usa-corporation-732874-07242026","During an inspection of your firm located in Lewisberry, PA from February 2, 2026 through March 27, 2026, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures dry and liquid hemodialysis dialysate con",0,[3,7,9,12,18],"1000142899","",""],["2026-07-24","Thomas Brunner Hygiene GmbH",0,6,"","Thomas Brunner","thomas-brunner-hygiene-gmbh-729018-07242026","This Warning Letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) review of your records. These violations were identified and documented during review of your drug manufacturing facility, Thomas Brunner Hygi",0,[3,4,6,13,16,17,18],"3035784232","",""],["2026-07-21","Koven Technologies, Inc.",2,2,"","Heather S. Bell","koven-technologies-inc-734643-07212026","During an inspection of your firm located in Saint Louis, MO, conducted from February 2, 2026, through February 6, 2026, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures and/or markets the Bidop 3",0,[10,12,18,20],"1937397","",""],["2026-07-16","Island Kinetics, Inc. d.b.a. CoValence Laboratories",0,6,"","Mr. Peter J. Vlcek","island-kinetics-inc-dba-covalence-laboratories-726379-07162026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Island Kinetics, Inc. d.b.a. CoValence Laboratories, FEI 3002408934, at 460 S. Benson Ln. Suite 1-3, Chandler, AZ, from January 14 to 23, 2026. This warning letter",0,[3,4,7,14,16,17,18],"3002408934","",""],["2026-07-14","NSE Products, Inc. DBA Nu Skin Enterprises, Inc.",0,0,"","Ryan Napierski","nse-products-inc-dba-nu-skin-enterprises-inc-722667-07142026","",0,[],"3001236514","",""],["2026-07-13","Almon Healthcare Private Limited",0,0,"","Mr. Rajesh Gandhi","almon-healthcare-private-limited-729291-07132026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Almon Healthcare Private Limited, FEI 3030509366, at Plot No 4, Sankalp Industrial Estate, Behind Kerala GIDC, Bavala, Ahmedabad, from February 9 to 13, 2026. This",0,[3,6,13,14,18],"3030509366","",""],["2026-07-13","BioMylz Pvt. Ltd.",0,6,"","Mr. Vasanth Samaga","biomylz-pvt-ltd-729483-07132026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, BioMylz Pvt. Ltd., FEI 3013697420, at #21 - D #21 - D Building No 1, Bengaluru, Karnataka, India, from February 4 to 9, 2026. This warning letter summarizes signif",0,[0,2,3,4,6,8,14,15,17,18],"3013697420","",""],["2026-07-13","Shimoga Chemicals",0,0,"","Mr. C. Srinivas Rao","shimoga-chemicals-727904-07132026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Shimoga Chemicals, FEI 3033881432, at W57A, MIDC, Kupwad, Sangli, Maharashtra, 416436, India, from January 19 to 23, 2026. This warning letter summarizes significa",0,[0,3,4,6,7,14,15,18],"3033881432","",""],["2026-07-10","Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd.",0,0,"","Pratik Doshi, M.D.","pratik-doshi-md-alembic-pharmaceuticals-ltd-731020-07102026","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at Alembic Research Centre in Vadodara, Gujarat, India, between March 3 and 7, 2025. The investigator representing FDA",0,[9],"","",""],["2026-07-08","Spa De Soleil, Inc.",0,6,"","Ms. Rena Revivo","spa-de-soleil-inc-728508-07082026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Spa De Soleil, Inc., FEI 3003876848, at 10443 Arminta Street, Sun Valley, from January 20 to 26, 2026. This warning letter summarizes significant violations of Cur",0,[2,4,5,7,13,14,15,18],"3003876848","",""],["2026-07-07","Specialty Health Products CO, LLC",2,2,"","John C. Kavanagh","specialty-health-products-co-llc-726564-07072026","During an inspection of your firm located in Phoenix, AZ, from December 1, 2025, through December 11, 2025, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures and markets the Hydro-San Colonic Irrigat",0,[0,10,11,12,17,18,20],"2027347","",""],["2026-07-02","International Medication Systems Limited",0,0,"","Dr. Jack Y. Zhang","international-medication-systems-limited-727560-07022026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, International Medication System Limited, FEI 2016148, at 1886 Santa Anita Avenue, South El Monte, from December 9 to 19, 2025. This warning letter summarizes signi",0,[1,2,8,10,14,18],"2016148","",""],["2026-06-24","Wizcure Pharmaa Private Limited",0,6,"","Mr. Ashish Arun Dange","wizcure-pharmaa-private-limited-726378-06242026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Wizcure Pharmaa Private Limited, 3030304532, located at H-881, Phase III, RIICO Industrial Area Bhiwadi, Rajasthan, India, from December 3 to 10, 2025. This warnin",0,[0,1,2,8,14,15,18],"3030304532","",""],["2026-06-23","All Ketamine HCL / www.allketaminehcl.com",0,0,"","","all-ketamine-hcl-wwwallketaminehclcom-725150-06232026","",0,[16,17,21],"","",""],["2026-06-23","Buy Keta Online / www.buyketaonline.com",0,0,"","","buy-keta-online-wwwbuyketaonlinecom-725145-06232026","",0,[16,17,21],"","",""],["2026-06-23","Extra Medication / www.extramedication.com",0,0,"","","extra-medication-wwwextramedicationcom-725152-06232026","",0,[16,17,21],"","",""],["2026-06-23","Ket Plug / ketaminelab.org and buyketaminepowderonline.com",0,0,"","","ket-plug-ketaminelaborg-and-buyketaminepowderonlinecom-728919-06232026","",0,[16,17,21],"3044408515","",""],["2026-06-23","Keta Med Lab / www.ketamedlab.com",0,0,"","","keta-med-lab-wwwketamedlabcom-725154-06232026","",0,[16,17,21],"","",""],["2026-06-23","Ketacyn Pharmaceuticals / www.ketacynpharma.com",0,0,"","","ketacyn-pharmaceuticals-wwwketacynpharmacom-725153-06232026","",0,[16,17,21],"","",""],["2026-06-23","Ketamine Store / www.ketaminestore.org",0,0,"","","ketamine-store-wwwketaminestoreorg-725147-06232026","",0,[16,17,21],"","",""],["2026-06-23","Ketamine Troche Store / www.ketaminetrochestore.com",0,0,"","","ketamine-troche-store-wwwketaminetrochestorecom-722122-06232026","",0,[16,17,21],"","",""],["2026-06-23","ketaminetroches.com",0,0,"","","ketaminetrochescom-725148-06232026","",0,[16,17,21],"","",""],["2026-06-23","Ketdaxandrugs / www.ketdaxandrugs.org",0,0,"","","ketdaxandrugs-wwwketdaxandrugsorg-725155-06232026","",0,[16,17,21],"","",""],["2026-06-23","Legit Ketamine Suppliers / www.legitketaminesuppliers.com",0,0,"","","legit-ketamine-suppliers-wwwlegitketaminesupplierscom-725149-06232026","",0,[16,17,21],"","",""],["2026-06-23","LyfeUnit / www.lyfeunit.com",0,0,"","","lyfeunit-wwwlyfeunitcom-725156-06232026","",0,[16,17,21],"","",""],["2026-06-23","Med Shop Inc / www.medshopinc.com",0,0,"","","med-shop-inc-wwwmedshopinccom-725157-06232026","",0,[16,17,21],"","",""],["2026-06-23","Pure Arylcyclohexylamine Store / www.arylcyclohexylamine.com",0,0,"","","pure-arylcyclohexylamine-store-wwwarylcyclohexylaminecom-725151-06232026","",0,[16,17,21],"","",""],["2026-06-22","Genzyme Ireland Limited",1,4,"","Mr. Cian O'Brien","genzyme-ireland-limited-728681-06222026","The United States Food and Drug Administration (FDA) inspected your facility, located at the above address, between January 12, 2026, and January 20, 2026. During the inspection, FDA documented evidence of significant violations of current good manufacturing p",0,[0,3,8,9,14,18],"3003809840","",""],["2026-06-17","Amazon.com, Inc.",0,0,"","Andy Jassy","amazoncom-inc-728814-06172026","",0,[16],"3016994737","",""],["2026-06-17","Great India Overseas Pvt. Ltd. dba Silkrute",0,0,"","Mohit Singla","great-india-overseas-pvt-ltd-dba-silkrute-729065-06172026","",0,[16,17],"3030661578","",""],["2026-06-17","Hadassah Healing Oils Ltd",0,0,"","","hadassah-healing-oils-ltd-729191-06172026","",0,[16],"3025348546","",""],["2026-06-17","Herbal Dermals LLC FZ dba Gotucream",0,0,"","","herbal-dermals-llc-fz-dba-gotucream-729043-06172026","",0,[16],"3040787677","",""],["2026-06-17","Indiangoods.shop",0,0,"","","indiangoodsshop-729068-06172026","",0,[16],"3044449203","",""],["2026-06-17","JJLBRO",0,0,"","","jjlbro-729873-06172026","",0,[16],"3044737849","",""],["2026-06-17","Leading Edge Health Inc.",0,0,"","","leading-edge-health-inc-729193-06172026","",0,[16],"3025721714","",""],["2026-06-17","MantroForce",0,0,"","","mantroforce-729021-06172026","",0,[16],"3044443397","",""],["2026-06-17","Telos Trading Limited dba Alwinshop",0,0,"","","telos-trading-limited-dba-alwinshop-729062-06172026","",0,[16,17],"3041903836","",""],["2026-06-17","Texinkart Inc.",0,0,"","","texinkart-inc-729046-06172026","",0,[16],"3030669002","",""],["2026-06-17","Wholesale Peptide",0,0,"","","wholesale-peptide-729447-06172026","",0,[16],"3044572435","",""],["2026-06-17","WHOOP, Inc.",2,2,"","Will Ahmed","whoop-inc-709755-06172026","Based on changes your firm has made to your \u201cBlood Pressure Insights\u201d product (\u201cBPI\u201d) and its labeling in response to our Warning Letter dated July 14, 2025, and consistent with the Food and Drug Administration\u2019s updated guidance document, General Wellness: Po",0,[],"3031627845","",""],["2026-06-17","Wild Arabic Herbs",0,0,"","","wild-arabic-herbs-729192-06172026","",0,[16],"3044447028","",""],["2026-06-16","4U Health",1,5,"","Alfred Caminos","4u-health-720527-06162026","The Food and Drug Administration (FDA) has completed evaluation of your firm's corrective actions in response to our Warning Letter dated March 17, 2026, set forth in your correspondence dated April 23, 2026. Based on your representation that 4U Health \u201chas di",0,[],"3036047066","",""],["2026-06-15","Happiest Baby, Inc.",2,2,"","Dr. Harvey Karp","happiest-baby-inc-718306-06152026","During an inspection of your firm located in Los Angeles, CA from July 21, 2025 through July 25, 2025, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the SNOO Smart Sleeper and the SNOO Hospital B",0,[10,17,18,20],"3030187577","",""],["2026-06-15","Huons Co., Ltd.",0,0,"","Mr. Jeong-woo Choo","huons-co-ltd-724650-06152026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Huons Co., Ltd., FEI 3007163376, located at 100 Bio Valley-ro, Jecheon, Chungcheongbuk, from November 12 to 21, 2025. This warning letter summarizes significant vi",0,[0,1,2,6,7,8,14,18],"3007163376","",""],["2026-06-15","Yangzhou Hongshengding Chemical Co., Ltd.",0,6,"","Mr. Allen Lu","yangzhou-hongshengding-chemical-co-ltd-729710-06152026","This Warning Letter advises you of significant violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and applicable regulations for Yangzhou Hongshengding Chemical Co., Ltd. (hereafter YHC), FEI 3013166766, located at No. 8, Sitong Road, Hangji Ind",0,[17,18],"3013166766","",""],["2026-06-12","Nihon Kohden Digital Health Solutions, LLC",2,2,"","Harsh Dharwad","nihon-kohden-digital-health-solutions-llc-727803-06122026","During an inspection of your firm located in Irvine, CA from February 23, 2026 through February 24, 2026, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Next Generation NetKonnect software d",0,[17,18,20],"3003142870","",""],["2026-06-08","Altru Telehealth, LLC dba Altru Telehealth",0,0,"","","altru-telehealth-llc-dba-altru-telehealth-728274-06082026","",0,[16,17],"3044020130","",""],["2026-06-08","Amie Health, Inc. dba Amie",0,0,"","","amie-health-inc-dba-amie-728276-06082026","",0,[16,17],"3044000672","",""],["2026-06-08","Clover Meds LLC dba Clover Meds",0,0,"","","clover-meds-llc-dba-clover-meds-728234-06082026","",0,[16,17],"3044175705","",""],["2026-06-08","D&H Medical Services",0,0,"","","dh-medical-services-728238-06082026","",0,[16,17],"3044174854","",""],["2026-06-08","Eden Health International Inc. dba Eden",0,0,"","","eden-health-international-inc-dba-eden-728279-06082026","",0,[16,17],"3044020039","",""],["2026-06-08","Ezra Holdco LLC dba Ezra",0,0,"","","ezra-holdco-llc-dba-ezra-730995-06082026","",0,[16,17],"3045074898","",""],["2026-06-08","FITISH",0,0,"","","fitish-728280-06082026","",0,[16,17],"3044018836","",""],["2026-06-08","FitRX, LLC dba AM RX",0,0,"","Kyle Robertson","fitrx-llc-dba-am-rx-728275-06082026","",0,[16,17],"3044021238","",""],["2026-06-08","Glow Medispa, LLC dba Mint Med",0,0,"","","glow-medispa-llc-dba-mint-med-730390-06082026","",0,[16,17],"3044896930","",""],["2026-06-08","HydraMed IV LLC dba HydraMed",0,0,"","","hydramed-iv-llc-dba-hydramed-728282-06082026","",0,[16,17],"3044021141","",""],["2026-06-08","Joi and Blokes dba Joi + Blokes",0,0,"","","joi-and-blokes-dba-joi-blokes-728283-06082026","",0,[16,17],"3044021205","",""],["2026-06-08","Maximus Health, Inc. dba Maximus",0,0,"","","maximus-health-inc-dba-maximus-730095-06082026","",0,[16,17],"3032037948","",""],["2026-06-08","Medica Weight Loss",0,0,"","","medica-weight-loss-728284-06082026","",0,[16,17],"3044019522","",""],["2026-06-08","Momentum Health 360 dba Momentum Health",0,0,"","","momentum-health-360-dba-momentum-health-728286-06082026","",0,[16,17],"3043997131","",""],["2026-06-08","NativeMed LLC dba NativeMed",0,0,"","","nativemed-llc-dba-nativemed-728287-06082026","",0,[16,17],"3044024130","",""],["2026-06-08","Nexlife Inc. dba Nexlife",0,0,"","","nexlife-inc-dba-nexlife-730096-06082026","",0,[16,17],"3044820290","",""],["2026-06-08","Nexus Health Solutions LLC dba Harper Meds",0,0,"","","nexus-health-solutions-llc-dba-harper-meds-728281-06082026","",0,[16,17],"3044020867","",""],["2026-06-08","Nova Vascular LLC dba NOVARX",0,0,"","","nova-vascular-llc-dba-novarx-728290-06082026","",0,[16,17],"3044022416","",""],["2026-06-08","OrderlyMeds LLC dba OrderlyMeds",0,0,"","Brian Spears, MD","orderlymeds-llc-dba-orderlymeds-728291-06082026","",0,[16,17],"3044027176","",""],["2026-06-08","Public Health Solution LLC dba DrMedHealth",0,0,"","","public-health-solution-llc-dba-drmedhealth-728278-06082026","",0,[16,17],"3044020737","",""],["2026-06-08","Ready Med",0,0,"","","ready-med-730317-06082026","",0,[16,17],"3044868483","",""],["2026-06-08","Roen Health, Inc. dba RoenRx",0,0,"","Kyle Robertson","roen-health-inc-dba-roenrx-728293-06082026","",0,[16,17],"3044022969","",""],["2026-06-08","Thrivelab Co. dba Thrivelab",0,0,"","Joshua Host","thrivelab-co-dba-thrivelab-728294-06082026","",0,[16,17],"3043997633","",""],["2026-06-08","Trinity HealthCare Supply, LLC dba altRx",0,0,"","","trinity-healthcare-supply-llc-dba-altrx-728236-06082026","",0,[16,17],"3044175714","",""],["2026-06-08","VivioMD Group LLC dba VivioMD",0,0,"","","viviomd-group-llc-dba-viviomd-728295-06082026","",0,[16,17],"3044027316","",""],["2026-06-05","Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil",0,0,"","Ms.Gulten Erdemir","delta-kozmetik-sanayi-ve-ticaret-selim-yesil-614402-06052026","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-23-11 dated February 13, 2023, and Warning Letter 320-21-51 dated July 8, 2021. Based on our evaluation, it appears that",0,[],"3010166780","",""],["2026-06-05","Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil",0,0,"","Ms. Gulten Erdemir","delta-kozmetik-sanayi-ve-ticaret-selim-yesil-645478-06052026","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-23-11 dated February 13, 2023, and Warning Letter 320-21-51 dated July 8, 2021. Based on our evaluation, it appears that",0,[],"3010166780","",""],["2026-06-05","Sante Manufacturing Inc.",0,6,"","Mr. Wayne Kirby","sante-manufacturing-inc-724931-06052026","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our July 7, 2025, request and subsequent correspondence f",0,[4,13,14,18],"3021535057","",""],["2026-06-04","AseptiKits, LLC",2,2,"","Gale H. Thorne Jr.","aseptikits-llc-728184-06042026","During an inspection of your firm located in North Salt Lake, UT from November 11, 2025, through December 3, 2025, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures and markets the PALA YourTears mod",0,[17,18,20],"3015422213","",""],["2026-06-03","BlephEx, LLC",2,2,"","James M. Rynerson, M.D.","blephex-llc-725861-06032026","During an inspection of your firm located in Brentwood, TN from October 30, 2025, through November 19, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the BlephEx Powered Eyelid Cleaning Sp",0,[10,11,17,18,20],"3010351679","",""],["2026-06-03","Hubei Gedian Humanwell Pharmaceutical Co., Ltd.",0,0,"","Dr. Hailin Chen","hubei-gedian-humanwell-pharmaceutical-co-ltd-725591-06032026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Hubei Gedian Humanwell Pharmaceutical Co., Ltd., FEI 3004117486, located at No. 25 Juxian Road, Gedian Economic Development District, Ezhou City, Hubei Province, C",0,[10,14,18],"3004117486","",""],["2026-06-03","InvaDerm, Inc.",0,0,"","Dilip Solanki","invaderm-inc-713177-06032026","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, InvaDerm, Inc. FEI 3010165760, at 25 Worlds Fair Drive, Somerset, NJ, from October 15 \u2013 17, 2024. In addition, following FDA\u2019s 2024 inspection, the Agency reviewed your fir",0,[16],"3010165760","",""],["2026-06-02","Erkul Kozmetik Sanayi ve Ticaret A.S.",0,0,"","Ms. Fatma Faize Aktar","erkul-kozmetik-sanayi-ve-ticaret-721964-06022026","Your facility was registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our August 25, 2025 request for records and other inform",0,[13,14,18],"3012641739","",""],["2026-06-02","Gopaldas Visram & Co., Ltd.",0,6,"","Mr. Mukund V. Thakker","gopaldas-visram-co-ltd-721755-06022026","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our August 14, 2025 request for records and other informa",0,[0,7,13,14,18],"3009565091","",""],["2026-06-02","Laboratorios Dr. Collado S.A.",0,6,"","Mr. Jos\u00e9 Miranda","laboratorios-dr-collado-sa-723285-06022026","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our August 25, 2025 request for records and other informa",0,[13,14,18],"3000989764","",""],["2026-06-02","PLZ Corp",0,0,"","Mr. Jigar Joshi","plz-corp-721140-06022026","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our September 8, 2025 request for records and other infor",0,[13,14,18],"3001956890","",""],["2026-06-02","Revlon Group Holdings, LLC",0,0,"","Mr. David Hamilton","revlon-group-holdings-llc-722596-06022026","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our September 8, 2025 request for records and other infor",0,[13,14,18],"1021184","",""],["2026-06-02","Shantou Qiwei Industry Co., LTD",0,6,"","Mr. Kunjiang Zhou","shantou-qiwei-industry-co-ltd-721753-06022026","Your facility was registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our August 14, 2025 request for records and other inform",0,[13,14,18],"3006784241","",""],["2026-06-02","Umendra Life Sciences Private Limited",0,6,"","Mr. Ankur Sharma Sr.","umendra-life-sciences-private-limited-721752-06022026","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our August 14, 2025 request for records and other informa",0,[13,14,18],"3035187076","",""],["2026-06-02","Zydus Lifesciences Limited",0,0,"","Dr. Sharvil Patel","zydus-lifesciences-limited-722576-06022026","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of prescription drug products. FDA has reviewed the records you submitted in response to our November 7, 2025 request for records and other information purs",0,[0,7,14,18],"3005430968","",""],["2026-05-29","Macau-Union Pharmaceutical Limited",0,0,"","Mr. Kin Va Choi","macau-union-pharmaceutical-limited-724506-05292026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Macau-Union Pharmaceutical Limited, FEI 3011219786, at 3-3A Rua Cinco Do Bairro Da Areia Preta, Room B 1/F, Industrial Veng Fong, from December 15 to 17, 2025. Thi",0,[3,4,6,13,14,16,17,18],"3011219786","",""],["2026-05-28","Jose M. Carpio, M.D.",0,0,"","Jose M. Carpio, M.D.","jose-m-carpio-md-730966-05282026","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between May 1 and May 13, 2025. The investigator representing FDA reviewed your conduct of the fo",0,[9],"3011073064","",""],["2026-05-28","Jubilant HollisterStier General Partnership",0,0,"","Mr. Christopher S. Preti","jubilant-hollisterstier-general-partnership-723537-05282026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Jubilant HollisterStier General Partnership, FEI 3001623073, at 16751 Trans-Canada Highway, Kirkland, from October 20 to November 3, 2025. This warning letter summ",0,[1,2,7,8,14,18],"3001623073","",""],["2026-05-28","Medline Inc",0,0,"","Mr. James Boyle","medline-inc-724347-05282026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Medline Industries, LP, FEI 3003983334, at 1710 South Lakeside Drive, Waukegan, Illinois, from October 6 to 14, 2025. This warning letter summarizes significant vi",0,[1,2,7,14,18],"3003983334","",""],["2026-05-27","Linemaster Switch Corporation",2,2,"","Joseph Carlone Jr.","linemaster-switch-corporation-730215-05272026","During an inspection of your firm located in Woodstock, CT from February 4, 2026, through March 6, 2026, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures foot pedal accessories for medical devices",0,[18,20],"3001592626","",""],["2026-05-27","Pharmathen International S.A.",0,0,"","Mr. John Pius Nason","pharmathen-international-sa-723680-05272026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Pharmathen International S.A., FEI 3009961173, at Industrial Park, Sapes Rodopi Prefecture, Block No 5 Rodopi, Evrou, Greece, from November 10 to 21, 2025. This wa",0,[1,2,7,8,14,15,18],"3009961173","",""],["2026-05-26","Blue Horizon International, LLC",1,4,"","Dr. Brian Mehling","blue-horizon-international-llc-728085-05262026","The United States Food and Drug Administration (FDA) reviewed your company\u2019s website at https://bluehorizonstemcells.com (last visited May 2026), through which your company markets \u201cStem Cell Therapy\u201d derived from umbilical cord blood and \u201cExosome Therapy\u201d 1 d",0,[16,17,19,21],"3010653480","",""],["2026-05-22","Aeroflex Industria de Aerosol Ltda.",0,6,"","Mr. M\u00e1rcio Paranhos Miksza","aeroflex-industria-de-aerosol-ltda-728186-05222026","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter drug products. Previous correspondence you sent to the FDA indicated manufacture and importation of multiple drug products. Additionally",0,[18],"3018057637","",""],["2026-05-22","Laboratorios Jaloma S.A. de C.V.",0,6,"","Mr. Jaime Labastida","laboratorios-jaloma-sa-de-cv-725939-05222026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Laboratorios Jaloma S.A. de C.V., FEI 3002600322, located at Calle Aquiles Serdan No. 438, Colonia Oblatos, Guadalajara, Jalisco, from December 15 to 19, 2025. Thi",0,[0,6,9,14,17,18],"3002600322","",""],["2026-05-22","ZIIP, Inc.",2,2,"","Mr. David Mason","ziip-inc-725870-05222026","During an inspection of your firm located in Pleasant Hill, CA from January 5, 2026, through January 12, 2026, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the ZIIP HALO device. Your website and",0,[9,10,12,18],"3029740697","",""],["2026-05-21","Alchymars ICM SM Private Limited",0,0,"","","alchymars-icm-sm-private-limited-724429-05212026","The United States Food and Drug Administration (FDA) conducted an unannounced inspection of your drug manufacturing facility, Alchymars ICM SM Private Limited, FEI 3005216842, at A-14 & 20 Sidco Pharmaceutical Complex, Alathur, Tamil Nadu, from November 28 to",0,[3,14,18],"3005216842","",""],["2026-05-20","3B Medical, Inc. dba Reach Health, Inc.",2,2,"","William H. Shoop","3b-medical-inc-dba-reach-health-inc-725108-05202026","During an inspection of your firm located in Dublin, OH from December 1, 2025 through December 10, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures iCodeConnect, a cloud-based software devic",0,[9,10,11,12,18,20],"3009096682","",""],["2026-05-20","BMC Medical Co., Ltd.",2,2,"","Jian Xu","bmc-medical-co-ltd-725759-05202026","During an inspection of 3B Medical, Inc. (d.b.a. React Health, Inc.) located at 5475 Rings Road, Dublin, OH 43017 from December 1, 2025 through December 10, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your fi",0,[17,18,20],"3008566132","",""],["2026-05-19","HealthPartners Neuroscience Center Research and Innovation",0,0,"","Leah R. Hanson, Ph.D.","healthpartners-neuroscience-center-research-and-innovation-725333-05192026","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at HealthPartners Neuroscience Center Research and Innovation (HPNC) between March 17 and 21, 2025. The investigators r",0,[9],"3013322165","",""],["2026-05-19","Skytron, LLC",2,2,"","David Mehney","skytron-llc-723950-05192026","",0,[3,17,18,20],"1825014","",""],["2026-05-18","Aja Health and Wellness Inc.",0,6,"","Sanjeev Parsad","aja-health-and-wellness-inc-729644-05182026","",0,[16,17],"","",""],["2026-05-18","GSC Products, LLC",0,6,"","Wayne Perry","gsc-products-llc-729653-05182026","",0,[16,17],"","",""],["2026-05-18","Sato Pharmaceutical Co., Ltd.",0,6,"","Seiichi Sato","sato-pharmaceutical-co-ltd-723059-05182026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Sato Pharmaceutical Co., Ltd., FEI 3004055563, located at 1468 Hazama-Machi, Hachioji, Tokyo, Japan, from November 13 to 21, 2025. This warning letter summarizes s",0,[1,6,18],"3004055563","",""],["2026-05-14","GC America, Inc.",0,6,"","Mr. Joseph T. Talanges","gc-america-inc-727602-05142026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, GC America, Inc., FEI 1410097, at 3737 West 127th Street, Alsip, Illinois, from November 3 to 7, 2025. This warning letter summarizes significant violations of Cur",0,[0,6,13,14,18],"","",""],["2026-05-14","Global Medical Production Co., Ltd.",2,2,"","Jeff Dai","global-medical-production-co-ltd-620544-05142026","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective and preventive actions in response to our Warning Letter (CMS # 620544) dated November 16, 2021. Based on our evaluation, it appears that your firm has adequately addr",0,[9],"3006897899","",""],["2026-05-14","La Crema De Rebeca",0,0,"","","la-crema-de-rebeca-728782-05142026","",0,[16,17,21],"3043047834","",""],["2026-05-14","Lus Essentials LLC",0,0,"","","lus-essentials-llc-728783-05142026","",0,[16,17,21],"3042850958","",""],["2026-05-14","PolleyMed, LLC",0,0,"","John W. Polley, MD","polleymed-llc-726018-05142026","",0,[16,17],"3038347614","",""],["2026-05-13","CSL Behring",1,4,"","Pamela Lee","csl-behring-716297-05132026","The Food and Drug Administration has completed evaluation of your corrective actions in response to our Warning Letter dated September 09, 2025. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. This l",0,[],"3000215763","",""],["2026-05-12","Fagron BV",0,0,"","Rafael Padilla","fagron-bv-724551-05122026","You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. \u00a7 353b] 1 on April 21, 2017, and most recently on November 22, 2025. From",0,[1,2,3,8,10,13,14,15,17,18,21],"3013438665","",""],["2026-05-04","IDO Pharm Co., Ltd.",0,0,"","Mr. Young Joo Kim","ido-pharm-co-ltd-723449-05042026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, IDO Pharm Co., Ltd., 3017021001, at 41 Beonnyeong-ro, 15 beon-gil, Danwon-gu District, Ansan-si, Gyeonggi-do, from November 10 to 13, 2025. This warning letter sum",0,[3,4,5,14,18],"3017021001","",""],["2026-05-04","Naseem A. Jaffrani, M.D.",0,0,"","","naseem-jaffrani-md-729750-05042026","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between February 24 and March 13, 2025. The investigator representing FDA reviewed your conduct o",0,[9],"","",""],["2026-05-04","Naveh Pharma LTD/Bigdam Inc.",0,0,"","Tal Bornstein, CEO","naveh-pharma-ltdbigdam-inc-724669-05042026","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites https://www.navehpharma.com/ and https://u-better.com/, and your Amazon storefront 1 in March 2026. The FDA has observed that you offer your products, \u201cRSV Hyp",0,[14,16,18],"3031820558","",""],["2026-05-01","Harbin Jixianglong Biotech Co., Ltd.",0,0,"","Mr. Guo Qing Leng","harbin-jixianglong-biotech-co-ltd-723330-05012026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Harbin Jixianglong Biotech Co., Ltd., FEI 3024038751, at North of Baoan Road, East of Changqing Street, Liminzhen Hulan District, Harbin, Heilongjiang, from Novemb",0,[2,3,4,5,6,7,13,14,15,17,18],"3024038751","",""],["2026-05-01","Quality CDMO, Inc.",0,0,"","Anin Shakiba","quality-cdmo-inc-665961-05012026-0","The U.S. Food and Drug Administration (FDA) has completed evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS 665961) dated September 11, 2024. Based on our evaluation, it appears that you have addressed the violations contained",0,[],"","",""],["2026-04-30","CareFusion 213, LLC",0,0,"","Mr. Thomas E. Polen, Jr.","carefusion-213-llc-722729-04302026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, CareFusion 213, LLC (a wholly-owned subsidiary of Becton, Dickinson and Company (BD)), FEI 3004932373, at 1550 Northwestern Drive, El Paso, Texas, from October 15",0,[1,2,3,7,8,10,13,14,18],"3004932373","",""],["2026-04-30","ZOLL Medical Corporation",2,2,"","","zoll-medical-corporation-711320-04302026","During an inspection of your firm located in Chelmsford, MA from February 27, 2025 through April 15, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures X Series/Advanced automated external def",0,[9,10,13,18,20,21],"1220908","",""],["2026-04-29","Mukesh B. Chandre, M.D., MBBS/Ashirwad Hospital & Research Centre",0,0,"","Mukesh B. Chandre, M.D., MBBS","mukesh-b-chandre-md-mbbsashirwad-hospital-research-centre-724911-04292026","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at Ashirwad Hospital & Research Centre in Ulhasnagar, Maharashtra, India, between May 5 and May 9, 2025. The investigat",0,[9],"","",""],["2026-04-29","Sourav K. Mishra, M.D. / All India Institute of Medical Sciences",0,0,"","Sourav K. Mishra, M.D.","sourav-k-mishra-md-all-india-institute-medical-sciences-724881-04292026","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at All India Institute of Medical Sciences in Bhubaneswar, Odisha, India, between March 17 and March 20, 2025. The inve",0,[],"","",""],["2026-04-24","ibeautistore.com",0,0,"","","ibeautistorecom-726302-04242026","",0,[16,17,21],"3042625970","",""],["2026-04-24","Ray\u2019s Vitamins",0,0,"","Rene Gonzalez","rays-vitamins-726694-04242026","",0,[16,17,21],"3042490356","",""],["2026-04-22","Active Cosmetics Manufacturing Inc.",0,0,"","Ms. Celia Ferreira","active-cosmetics-manufacturing-inc-722408-04222026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Active Cosmetics Manufacturing Inc., FEI 3005351079, at 7075 Kingspointe Parkway, Suites 2, 3, 4, and 5, Orlando, from October 27 to 31, 2025. This warning letter",0,[4,7,8,13,14,17,18],"3005351079","",""],["2026-04-22","Estar Technologies Ltd",1,10,"","Aaron Esteron","estar-technologies-ltd-716831-04222026","The United States Food and Drug Administration (FDA) has learned that your firm is offering for sale the Tropocells\u00ae PRP kit, Tropocells\u00ae PRF kit, Tropocells\u00ae TRS kit, Tropocells\u00ae PRFM kit, TropoVisc\u2122 kit, Tropokine\u2122 kit, and Cellenis\u00ae PRP kit (hereafter, \u201cyou",0,[17,18,20],"3002047500","",""],["2026-04-20","Foshan Miwei Cosmetics Co., Ltd.",0,6,"","Mr. Zhong Muqi","foshan-miwei-cosmetics-co-ltd-722272-04202026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Foshan Miwei Cosmetics Co., Ltd., FEI 3017118698, located at 801 & 802, Building 9, Baofa Jewellery Industry Centre, No. 1, Feicui Road, Yang\u2019e Village Committee,",0,[6,7,13,14,16,17,18],"3017118698","",""],["2026-04-20","Respilon Production S.R.O.",0,6,"","Mr. Roman Zima","respilon-production-sro-719705-04202026","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our May 2, 2025, request and subsequent correspondence, f",0,[4,5,6,13,18],"3018892481","",""],["2026-04-17","SaNOtize",0,0,"","Mikael Svensson","sanotize-727784-04172026","",0,[16],"3016964001","",""],["2026-04-15","Hangzhou Yiqi Biotechnology Co., Ltd",0,0,"","Mr. Jack Chai","hangzhou-yiqi-biotechnology-co-ltd-720707-04152026","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of active pharmaceutical ingredients (APIs). FDA has reviewed the records you submitted in response to our June 16, 2025, request and subsequent corresponde",0,[4,5,6,17,18],"3035145155","",""],["2026-04-15","JW Nutritional LLC",0,6,"","Mr. Jesse Windrix","jw-nutritional-llc-722096-04152026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, JW Nutritional LLC, FEI 3031468435, at 4700 S. Hardin Blvd., Suite 260, McKinney, TX, from September 22 to 26, 2025. This warning letter summarizes significant vio",0,[4,13,18],"3031468435","",""],["2026-04-15","Par Health USA, LLC & Endo USA, Inc.",0,0,"","Mr. John Caldwell","par-health-usa-llc-endo-usa-inc-722121-04152026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, ENDO USA, Inc., FEI 1818977, at 870 Parkdale Road, Rochester, from October 6 to 20, 2025. This warning letter summarizes significant violations of Current Good Man",0,[1,2,8,13,14,18],"1818977","",""],["2026-04-15","Unetixs Vascular, Inc.",2,2,"","Mr. Neeraj Jha","unetixs-vascular-inc-724245-04152026","During an inspection of your firm, Unetixs Vascular, Inc., located in Warwick, RI from September 19, 2025, through December 4, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures vascular diagn",0,[17,18,20],"1222117","",""],["2026-04-14","Ava Inc.",0,0,"","Dr. Ram P. Chakroborty","ava-inc-721180-04142026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Ava Inc., FEI 3008736380, at 7051 S. Adams St., Willowbrook, IL, from October 6 to October 21, 2025. This warning letter summarizes significant violations of Curre",0,[0,5,7,14,15,18],"3008736380","",""],["2026-04-14","New Life Pharma LLC",0,0,"","Mr. Arthur Leong","new-life-pharma-llc-725661-04142026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, New Life Pharma LLC, 3012113519, at 265 Livingston Street, Northvale, from February 3 to February 13, 2026. Based on the inspection and a review of the evidence co",0,[1,2,3,8,14,16,17,18],"3012113519","",""],["2026-04-14","Pro Numb Tattoo Numbing Spray, LLC",0,0,"","Mr. Justin T. Zahnter","pro-numb-tattoo-numbing-spray-llc-722589-04142026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Pro Numb Tattoo Numbing Spray, LLC, FEI 3027228716, at 3778 Dixie Highway NE, Suite C, Palm Bay, from November 5 to 6, 2025. This warning letter summarizes signifi",0,[0,4,6,13,14,16,17,18],"3027228716","",""],["2026-04-13","UCSF Radiopharmaceutical Facility",0,0,"","Dr. Robin C. Cumming","ucsf-radiopharmaceutical-facility-719568-04132026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, UCSF Radiopharmaceutical Facility, FEI 3005947301, at 185 Berry St. Ste. 350, San Francisco, from July 21 to 24, 2025. This warning letter summarizes significant v",0,[1,2,7,8,14,18],"3005947301","",""],["2026-04-09","Medical Products Laboratories, Inc.",0,0,"","Mr. Elliot Stone","medical-products-laboratories-inc-721916-04092026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Medical Products Laboratories, Inc., FEI 2513595, at 9990 Global Road, Philadelphia, from September 29 to October 16, 2025. This warning letter summarizes signific",1,[2,4,6,7,14,16,18],"2513595","",""],["2026-04-08","LaseTech LLC",2,2,"","Mohamed Alamin","lasetech-llc-702493-04082026","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 702493, dated March 19, 2025). Based on our evaluation, it appears that you have addressed the violations contained in this",0,[],"3015730775","",""],["2026-04-07","Chemco Corporation",0,6,"","Mr. Eitelberg G. Montarroyos, Sr.","chemco-corporation-721592-04072026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Chemco Corporation, FEI 1042599, at 4920 NW 165th St., Miami Lakes, from August 11 to 22, 2025. This warning letter summarizes significant violations of Current Go",0,[3,4,7,13,14,16,17,18],"1042599","",""],["2026-04-07","Lexia LLC",0,6,"","Mrs. Lois F. Elliott","lexia-llc-722251-04072026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Lexia LLC, FEI 3011863647, at 367 Riverside Drive, Suite 1003, Franklin, TN, from September 23 to 29, 2025. This warning letter summarizes significant violations o",1,[4,6,13,14,17,18],"3011863647","",""],["2026-04-07","ProRx LLC",0,0,"","Arthur Fletcher","prorx-llc-723704-04072026","You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. \u00a7 353b] 1 on April 27, 2022, and most recently on February 20, 2026. From",0,[0,1,2,3,7,8,11,14,15,16,17,18,21],"3022250654","",""],["2026-04-02","Beauty of Aztlan LLC",0,0,"","","beauty-aztlan-llc-723532-04022026","",1,[16,17,21],"","",""],["2026-04-02","Purolea Cosmetics Lab",0,0,"","Ms. Maria N. Mattina","purolea-cosmetics-lab-722591-04022026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Purolea Cosmetics Lab, FEI 3011669383, at 12782 Currie Ct., Livonia, from October 28 to 30, 2025. Your drug products are adulterated under section 501(a)(2)(A) of",1,[4,10,13,14,15,16,17,18],"3011669383","",""],["2026-04-01","Dry Springs Pharmacy",0,0,"","","dry-springs-pharmacy-723460-04012026","",1,[16,17,21],"","",""],["2026-04-01","Online Rx Medz",0,0,"","","online-rx-medz-723472-04012026","",1,[16,17,21],"","",""],["2026-04-01","Pure Indulgence Aesthetics",0,0,"","Bridget M. Goddard","pure-indulgence-aesthetics-723267-04012026","",1,[],"3041017461","",""],["2026-04-01","Rxgoodusa",0,0,"","","rxgoodusa-723622-04012026","",1,[16,17,21],"","",""],["2026-03-31","FormPour",0,0,"","Shuja Arshad","formpour-722215-03312026","",1,[16],"3042836048","",""],["2026-03-31","Gram Peptides",0,0,"","Bernard Gramlich","gram-peptides-721806-03312026","",1,[16],"3042657277","",""],["2026-03-31","Guangzhou Huli Technology Co., Ltd. dba Fantasy Face",0,0,"","Haijie Long","guangzhou-huli-technology-co-ltd-dba-fantasy-face-722228-03312026","",1,[16],"3042834371","",""],["2026-03-31","Lovega LLC dba Pink Pony Peptides",0,0,"","Susan Vega","lovega-llc-dba-pink-pony-peptides-721088-03312026","",1,[16],"3042290626","",""],["2026-03-31","Mile High Compounds LLC",0,0,"","Max Radovanic","mile-high-compounds-llc-721600-03312026","",1,[16],"3042347604","",""],["2026-03-31","PekCura Labs",0,0,"","Jonathan Snider, Owner","pekcura-labs-721709-03312026","",1,[16],"3042624367","",""],["2026-03-31","Prime Sciences",0,0,"","","prime-sciences-721805-03312026","",1,[16],"3042657272","",""],["2026-03-30","Intas Pharmaceuticals Limited",0,0,"","Mr. Kirti Maheshwari","intas-pharmaceuticals-limited-721151-03302026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Intas Pharmaceuticals Limited, FEI 3005890633, located at Camp Road, Selaqui, Dehradun, from September 8 to 17, 2025. This warning letter summarizes significant vi",1,[0,5,7,9,14,15,18],"3005890633","",""],["2026-03-27","Early to Bed, Inc.",2,2,"","Searah Deysach","early-bed-inc-720822-03272026","The Food and Drug Administration (FDA) has completed an evaluation of Early to Bed, Inc. corrective actions in response to our Warning Letter CMS #720822, dated December 16th, 2025. Based on our evaluation, it appears that you have addressed the violation(s) c",0,[],"3003879277","",""],["2026-03-27","Ehsan Sadri, M.D.",0,0,"","","ehsan-sadri-md-726342-03272026","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between March 27 and April 16, 2025. The investigators representing FDA reviewed your conduct of",1,[9],"3027872855","",""],["2026-03-27","FLAVNT Streetwear, LLC",2,2,"","Christopher Rhodes","flavnt-streetwear-llc-720838-03272026","The Food and Drug Administration (FDA) has completed an evaluation of FLAVNT Streetwear, LLC corrective actions in response to our Warning Letter CMS #720838, dated December 16th, 2025. Based on our evaluation, it appears that you have addressed the violation(",0,[],"3042194473","",""],["2026-03-27","Flux Lab Pte. Ltd. d/b/a The Fluxion",2,2,"","Yan Nie","flux-lab-pte-ltd-dba-fluxion-720847-03272026","The Food and Drug Administration (FDA) has completed an evaluation of Flux Lab Pte. Ltd. d/b/a The Fluxion corrective actions in response to our Warning Letter CMS #720847, dated December 16th, 2025. Based on our evaluation, it appears that you have addressed",0,[],"3042197030","",""],["2026-03-27","GenderBender LLC",2,2,"","Xander Shephard","genderbender-llc-720842-03272026","The Food and Drug Administration (FDA) has completed an evaluation of GenderBender LLC corrective actions in response to our Warning Letter CMS #720842, dated December 16th, 2025. Based on our evaluation, it appears that you have addressed the violation(s) con",0,[],"3042194571","",""],["2026-03-27","Marli Washington Design, LLC",2,2,"","Marli Washington","marli-washington-design-llc-720840-03272026","The Food and Drug Administration (FDA) has completed an evaluation of Marli Washington Design, LLC d/b/a gc2b corrective actions in response to our Warning Letter CMS #720840, dated December 16th, 2025. Based on our evaluation, it appears that you have address",0,[],"3042193199","",""],["2026-03-27","Philadelphia 7, Inc d/b/a Passional Boutique",2,2,"","Dumesh Kankanamalage","philadelphia-7-inc-dba-passional-boutique-720843-03272026","The Food and Drug Administration (FDA) has completed an evaluation of Philadelphia 7, Inc d/b/a Passional Boutique corrective actions in response to our Warning Letter CMS #720843, dated December 16th, 2025. Based on our evaluation, it appears that you have ad",0,[],"3042194976","",""],["2026-03-27","TG Supply LLC d/b/a TransGuy Supply",2,2,"","Anthony Guajardo","tg-supply-llc-dba-transguy-supply-720846-03272026","The Food and Drug Administration (FDA) has completed an evaluation of TG Supply LLC d/b/a TransGuy Supply corrective actions in response to our Warning Letter CMS #720846, dated December 16th, 2025. Based on our evaluation, it appears that you have addressed t",0,[],"3042197021","",""],["2026-03-27","For Them, Inc.",2,2,"","Kylo Freeman","them-inc-720839-03272026","The Food and Drug Administration (FDA) has completed an evaluation of For Them, Inc. corrective actions in response to our Warning Letter CMS #720839, dated December 16th, 2025. Based on our evaluation, it appears that you have addressed the violation(s) conta",0,[],"3042194959","",""],["2026-03-27","TomboyX, PBC",2,2,"","Fran Dunaway","tomboyx-pbc-720849-03272026","The Food and Drug Administration (FDA) has completed an evaluation of TomboyX, PBC corrective actions in response to our Warning Letter CMS #720849, dated December 16th, 2025. Based on our evaluation, it appears that you have addressed the violation(s) contain",0,[],"3031304636","",""],["2026-03-27","TOMSCOUT",2,2,"","Lim Tong Moi","tomscout-720850-03272026","The Food and Drug Administration (FDA) has completed an evaluation of TOMSCOUT corrective actions in response to our Warning Letter CMS #720850, dated December 16th, 2025. Based on our evaluation, it appears that you have addressed the violation(s) contained i",0,[],"3042195147","",""],["2026-03-25","Medline Industries, LP",2,2,"","Jim Boyle","medline-industries-lp-723866-03252026","During an inspection of your firm, Medline Industries, LP (NAMIC Division), located at 10 Glens Falls Tech Park, Glen Falls, NY 12801, from December 1, 2025 through December 12, 2025, an investigator from the United States Food and Drug Administration (FDA) de",1,[9,18,20],"3015910259","",""],["2026-03-23","Tailstorm Health Inc. dba Medivant Health",0,0,"","Viraj Gandhi","tailstorm-health-inc-dba-medivant-health-703497-03232026","The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our warning letter #703497, issued on April 8, 2025. Based on our evaluation, it appears that you have adequately addressed the violations",0,[],"3022483154","",""],["2026-03-23","Xiamen Kang Zhongyuan Biotechnology Co., Ltd.",0,0,"","Mr. Haisen Yang","xiamen-kang-zhongyuan-biotechnology-co-ltd-719320-03232026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Xiamen Kang Zhongyuan Biotechnology Co., Ltd., FEI 3027976266, at No. 2018-2, Jietou Road, Xiang\u2019an District, Xiamen, Fujian 361101, China, from August 12 to 15, 2",0,[0,17,18],"3027976266","",""],["2026-03-20","RC Outsourcing, LLC",0,0,"","Raymond R. Carlson","rc-outsourcing-llc-722877-03202026","You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. \u00a7 353b] 1 on October 7, 2015, and most recently on November 27, 2025.",0,[1,2,5,7,8,9,14,15,16,17,18,21],"3011967886","",""],["2026-03-18","Yangzhou H&R Plastic Daily Chemical Co., Ltd.",0,0,"","Mr. Jingcheng Gao","yangzhou-hr-plastic-daily-chemical-co-ltd-722736-03182026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Yangzhou H&R Plastic Daily Chemical Co., Ltd., FEI 3014543859, at 188 Xingyuan Road, Hangji, Guangling, Yangzhou, Jiangsu, from October 21 to 24, 2025. This warnin",1,[4,6,13,14,15,18],"3014543859","",""],["2026-03-17","4U Health",1,4,"","Alfred Caminos","4u-health-720527-03172026","The United States Food and Drug Administration (FDA or the Agency) has learned that your firm, 4U Health, is offering for sale in the United States a human immunodeficiency virus (HIV) serological diagnostic dried blood spot (DBS) card self-collection kit (her",0,[17,18,20],"3036047066","",""],["2026-03-16","Microbiological Testing & Consulting, LLC",0,0,"","Ms. Lauren Szarzynski","microbiological-testing-consulting-llc-720374-03162026","The United States Food and Drug Administration (FDA) inspected your contract testing laboratory, Microbiological Testing & Consulting, LLC, FEI 3003875820, at 5661 W. 120th Street, Alsip, from September 8 to 16, 2025. This warning letter summarizes significant",1,[0,7,14,18],"3003875820","",""],["2026-03-12","Patcos Cosmetics Pvt. Ltd.",0,6,"","Mr. Vimal Patel Director","patcos-cosmetics-pvt-ltd-718220-03122026","The United States Food and Drug Administration (FDA) conducted an unannounced inspection of your drug manufacturing facility, Patcos Cosmetics Pvt. Ltd., FEI 3009250196, at Survey No. 659, A Kevdi Falia Road, Daman, Dadra and Nagar Haveli and Daman, India, fro",1,[0,3,4,5,6,7,13,14,18],"3009250196","",""],["2026-03-11","Flowchem Pharma Private Limited",0,0,"","Mr. Anjan K. Roy","flowchem-pharma-private-limited-720719-03112026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Flowchem Pharma Private Limited, FEI 3019853324, at Plot No. 2B-2 & 2C, Survey No. 7(p) & 8(p), Gollapuram Industrial Park, Hindupur Taluk, Andhra Pradesh, from Se",1,[3,4,7,13,14,18],"3019853324","",""],["2026-03-11","OraLabs, Inc.",0,6,"","Mr. Gary Schlatter","oralabs-inc-720690-03112026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, OraLabs Inc., FEI 3001237145, at 18685 East Plaza Drive, Parker, from September 22 to 26, 2025. This warning letter summarizes significant violations of Current Go",1,[2,7,14,18],"3001237145","",""],["2026-03-09","Vedic Lifesciences Pvt. Ltd.",0,0,"","Jayesh Chaudhary","vedic-lifesciences-pvt-ltd-722446-03092026","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted between January 13 and 15, 2025. The investigators representing FDA reviewed the role of Vedic Lifesciences Pvt. Ltd. (",1,[9],"3012264895","",""],["2026-03-05","Novo Nordisk Inc.",0,0,"","Mr. David S. Moore","novo-nordisk-inc-717576-03052026","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your firm, Novo Nordisk Inc. (hereinafter referred to as NNI), between January 13 and February 7, 2025. The investig",1,[9],"2244771","",""],["2026-03-04","Citra100mg",0,0,"","","citra100mg-722606-03042026","",1,[16,17,21],"","",""],["2026-03-04","LifeVac, LLC",2,18,"","Mr. Arthur Lih","lifevac-llc-713455-03042026","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 713455, dated September 18, 2025). Based on our evaluation, it appears that you have addressed the violations contained in t",0,[],"3011053282","",""],["2026-03-03","Fareva Morton Grove",0,6,"","Mr. Bernard Fraisse","fareva-morton-grove-719408-03032026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Fareva Morton Grove, FEI 1410794, at 6901 Golf Road, Morton Grove, Illinois, from August 4 to 12, 2025. This warning letter summarizes significant violations of Cu",1,[0,14,17,18],"1410794","",""],["2026-03-03","Simtra BioPharma Solutions",0,0,"","Franco Negron","simtra-biopharma-solutions-720436-03032026","The United States Food and Drug Administration (FDA) conducted an unannounced inspection of your drug manufacturing facility, Simtra Deutschland GmbH, formerly Baxter Oncology GmbH, FEI 3002806419, at Kantstr. 2, 33790 Halle/Westphalia, Germany, from September",1,[1,2,4,8,18],"3002806419","",""],["2026-03-03","Tentamus India Private Limited",0,0,"","Mr. M. Jayapal Reddy","tentamus-india-private-limited-720463-03032026","The United States Food and Drug Administration (FDA) inspected your contract testing laboratory, Tentamus India Private Limited, FEI 3010960741, at 3-31/33, Part Sy. No. 123, 124,125 & 142, Kompally, Quthbullapur, Hyderabad, Telangana State, from August 14 to",1,[0,5,7,14,18],"3010960741","",""],["2026-03-02","NSE Products, Inc. DBA Nu Skin Enterprises, Inc.",0,0,"","Ryan Napierski","nse-products-inc-dba-nu-skin-enterprises-inc-722667-03022026","",0,[],"3001236514","",""],["2026-02-26","Longhorn Vaccines and Diagnostics LLC",2,2,"","Jeffrey D. Fischer","longhorn-vaccines-and-diagnostics-llc-721702-02262026","During an inspection of your firm located in Bethesda, MD from October 20, 2025 through October 30, 2025, investigators from the United States Food and Drug Administration (FDA) determined that your firm is a specification developer of the PrimeStore\u00ae MTM (Mol",1,[9,10,11,12,13,17,18,20],"3011818318","",""],["2026-02-26","Rontis Hellas S.A.",2,2,"","Mr. Anastasios Politopoulos","rontis-hellas-sa-695160-02262026","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS #695160 dated October 28, 2024). Based on our evaluation of the evidence provided in your Warning Letter response #5 (received",0,[],"3011142981","",""],["2026-02-25","Dr. Joel Kaplan, Inc.",2,2,"","Mr. Shumuel Itshaki","dr-joel-kaplan-inc-667193-02252026","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 667193, dated January 8, 2024). Based on our evaluation, it appears that you have addressed the violation(s) contained in th",0,[],"3001890611","",""],["2026-02-24","Azurity Pharmaceuticals, Inc.",0,0,"","Mr. Ronald Scarboro","azurity-pharmaceuticals-inc-656489-02242026","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (656489) dated September 20, 2024. Based on our evaluation, it appears that you have addressed the violations contained in th",0,[],"3003395329","",""],["2026-02-24","IsoTis OrthoBiologics, Inc.",2,2,"","Peter P. Nalbach","isotis-orthobiologics-inc-723370-02242026","During an inspection of your firm located in Irvine, CA from October 6, 2025, through October 17, 2025, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures resorbable calcium salt bone void filler devi",1,[4,9,18,20],"3001503333","",""],["2026-02-20","24HrDoc, Inc. dba 24HrDoc",0,0,"","","24hrdoc-inc-dba-24hrdoc-717984-02202026","",0,[16,17],"3039605314","",""],["2026-02-20","Alan Health Technologies Inc. dba Alan",0,0,"","","alan-health-technologies-inc-dba-alan-721814-02202026","",0,[16,17],"3042656672","",""],["2026-02-20","Aspen Aesthetics dba Fifty 410",0,0,"","","aspen-aesthetics-dba-fifty-410-721481-02202026","",1,[16,17],"3042457737","",""],["2026-02-20","Belle Health LLC dba Belle",0,0,"","","belle-health-llc-dba-belle-721795-02202026","",0,[16,17],"3042594169","",""],["2026-02-20","Better Health Labs, Inc. dba Measured",0,0,"","","better-health-labs-inc-dba-measured-721454-02202026","",0,[16,17],"3042458177","",""],["2026-02-20","Bliv Wellness LLC dba Bliv",0,0,"","","bliv-wellness-llc-dba-bliv-721479-02202026","",1,[16,17],"3042457729","",""],["2026-02-20","BluefitMD",0,0,"","","bluefitmd-721446-02202026","",1,[16,17],"3042456169","",""],["2026-02-20","Deluxe IV Aesthetics PLLC dba Deluxe IV and Aesthetics",0,0,"","","deluxe-iv-aesthetics-pllc-dba-deluxe-iv-and-aesthetics-721447-02202026","",1,[16,17],"3040801293","",""],["2026-02-20","Dripgym Mobile Parent, LLC dba Amp Health",0,0,"","","dripgym-mobile-parent-llc-dba-amp-health-717992-02202026","",0,[16,17],"3040748550","",""],["2026-02-20","FitRX, LLC dba FitRx",0,0,"","","fitrx-llc-dba-fitrx-717987-02202026","",1,[16,17],"3040746842","",""],["2026-02-20","Genesis Health International Inc. dba Genesis",0,0,"","","genesis-health-international-inc-dba-genesis-721451-02202026","",1,[16,17],"3042457394","",""],["2026-02-20","Good Girl LLC dba GoodGirlRX",0,0,"","Savannah Chrisley","good-girl-llc-dba-goodgirlrx-721449-02202026","",0,[16,17],"3042456235","",""],["2026-02-20","Ivim Services LLC dba Ivim",0,0,"","","ivim-services-llc-dba-ivim-721816-02202026","",0,[16,17],"3042656732","",""],["2026-02-20","Join Josie",0,0,"","","join-josie-717986-02202026","",0,[16,17],"3040746017","",""],["2026-02-20","Kare Solutions, LLC dba Zappy",0,0,"","","kare-solutions-llc-dba-zappy-717991-02202026","",0,[16,17],"3040748414","",""],["2026-02-20","Kin Meds",0,0,"","","kin-meds-721450-02202026","",0,[16,17],"3040775708","",""],["2026-02-20","Lean Rx, Inc. dba SkinnyRx",0,0,"","","lean-rx-inc-dba-skinnyrx-717989-02202026","",0,[16,17],"3040745670","",""],["2026-02-20","Levity Inc. dba Levity",0,0,"","","levity-inc-dba-levity-717990-02202026","",0,[16,17],"3040747648","",""],["2026-02-20","MaxLife Technologies Inc. dba Maxlife",0,0,"","","maxlife-technologies-inc-dba-maxlife-721453-02202026","",0,[16,17],"3042458079","",""],["2026-02-20","MEDVi, LLC dba MEDVi",0,0,"","","medvi-llc-dba-medvi-721455-02202026","",0,[16,17],"3040801321","",""],["2026-02-20","Newman Clinic, PLLC dba Newman Clinic",0,0,"","Donna Newman, DMSc, PA-C","newman-clinic-pllc-dba-newman-clinic-721470-02202026","",0,[16,17],"3040801323","",""],["2026-02-20","NewSelf Limited dba NewSelf",0,0,"","","newself-limited-dba-newself-721472-02202026","",0,[16,17],"3042457659","",""],["2026-02-20","Peaks Curative, LLC dba Peaks",0,0,"","","peaks-curative-llc-dba-peaks-721817-02202026","",0,[16,17],"3042656515","",""],["2026-02-20","PharmaZee",0,0,"","","pharmazee-721473-02202026","",0,[16,17],"3040779194","",""],["2026-02-20","Premium Health Management Inc. dba Premium Health",0,0,"","","premium-health-management-inc-dba-premium-health-721474-02202026","",1,[16,17],"3040775723","",""],["2026-02-20","Refills Health, LLC dba Refills Health",0,0,"","","refills-health-llc-dba-refills-health-721475-02202026","",0,[16,17],"3040801458","",""],["2026-02-20","Strut Health, LLC dba Strut",0,0,"","Simal Patel, MD","strut-health-llc-dba-strut-721448-02202026","",0,[16,17],"3042457354","",""],["2026-02-20","Viv Health, Inc. dba VIV RX",0,0,"","","viv-health-inc-dba-viv-rx-721818-02202026","",0,[16,17],"3042656603","",""],["2026-02-20","Weightless Medical LLC dba WeightCare",0,0,"","","weightless-medical-llc-dba-weightcare-721478-02202026","",0,[16,17],"3042457719","",""],["2026-02-20","Zeuss LLC dba Zeuss",0,0,"","","zeuss-llc-dba-zeuss-717985-02202026","",0,[16,17],"3040743981","",""],["2026-02-12","AQ USA Inc., d.b.a Ross Healthcare Inc.",0,0,"","Mr. Marc N. Ross","aq-usa-inc-dba-ross-healthcare-inc-719517-02122026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, AQ USA Inc., d.b.a Ross Healthcare Inc., FEI 3015167023, at 210 S Duffner Dr., Suite A, Lynden, from July 30 to August 12, 2025. We note that Ross Healthcare Inc.",0,[2,4,5,6,7,13,14,15,18],"3015167023","",""],["2026-02-12","A. Nelson & Co. Ltd.",0,0,"","Michael Lockett","nelson-co-ltd-720283-02122026","The United States Food and Drug Administration (FDA) conducted an unannounced inspection of your drug manufacturing facility, A. Nelson & Co., Ltd., FEI 1000568184, at 5 Endeavour Way, London, from September 15 to 19, 2025. This warning letter summarizes signi",0,[0,6,14,18],"1000568184","",""],["2026-02-11","Dynamic Stem Cell Therapy",1,4,"","Dale Carrison, D.O., FACEP, FACOEP","dynamic-stem-cell-therapy-712579-02112026","The United States Food and Drug Administration (FDA) reviewed your company\u2019s website at https://stemcellpowernow.com (last visited February 2026), through which your company markets an umbilical cord-derived stem cell product for allogeneic use (hereinafter, \u201c",0,[16,17,19,21],"3016196250","",""],["2026-02-10","Germaphobix",1,4,"","Jon Tavarez","germaphobix-720555-02102026","The Food and Drug Administration (FDA) has completed evaluation of your firm's corrective actions in response to our Warning Letter dated January 09, 2026, set forth in your correspondence dated January 20, 2026. Based on your representation that Germaphobix h",0,[],"3036047763","",""],["2026-02-10","ProDx Health",1,4,"","Andreas Kogelnik, MD, PhD","prodx-health-720762-02102026","The United States Food and Drug Administration (FDA or the Agency) has learned that your firm, ProDx Health, is offering for sale in the United States human immunodeficiency virus (HIV) serological diagnostic sample self-collection kits (hereinafter, your \u201csam",0,[17,18,20],"3042120427","",""],["2026-02-09","Sperm Bank, Inc. dba Fertility Center of California",1,4,"","Martin D. Bastuba, M.D.","sperm-bank-inc-dba-fertility-center-california-694273-02092026","The Food and Drug Administration has completed evaluation of your corrective actions in response to our Warning Letter CBER 25-694273 dated February 14, 2025. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warnin",0,[],"3005211905","",""],["2026-02-09","Thrive Health and Wellness, LLC dba Thrive Health Solutions",0,0,"","Doug Hatch","thrive-health-and-wellness-llc-dba-thrive-health-solutions-714891-02092026","From March 25, 2025, to April 3, 2025, a U.S. Food and Drug Administration (FDA) investigator inspected your facility, Thrive Health and Wellness, LLC dba Thrive Health Solutions, located at 88 Inverness Circle E Ste A-204, Englewood, CO 80112. During the insp",0,[1,2,16,17,18,21],"3033176989","",""],["2026-02-09","VeganicSKN Limited",0,0,"","Mr. Joseph Mizikovsky","veganicskn-limited-719883-02092026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, VeganicSKN Limited, FEI 3024609429, at 81 Shettleston Street, Unit III, Rocklea, Queensland, Australia, from July 15 to 21, 2025. This warning letter summarizes si",0,[7,13,14,18],"3024609429","",""],["2026-02-06","Cosmetic Manufacturers Pty Ltd.",0,0,"","Mr. Valentine P. Fittler","cosmetic-manufacturers-pty-ltd-719225-02062026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Cosmetic Manufacturers (Aust) Pty Ltd., FEI 3007187387, at 14 Kingston Drive, Helensvale, Queensland, from March 31 to April 8, 2025. This warning letter summarize",0,[2,3,4,8,18],"3007187387","",""],["2026-02-06","ExThera Medical Corporation",2,2,"","Erin R. Borger","exthera-medical-corporation-715068-02062026","This Warning Letter is to inform you of objectionable conditions observed during the Food and Drug Administration (FDA) inspection conducted at ExThera Medical Corporation (ExThera) from May 27, 2025, to June 4, 2025, by an investigator from the FDA\u2019s Office o",0,[17,18,20],"3014015528","",""],["2026-02-05","Beach Weekend Management LLC dba Nic and Jet Fuel",0,0,"","James Nabors III","beach-weekend-management-llc-dba-nic-and-jet-fuel-719715-02052026","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://nicandjetfuel.com/ in November 2025. The FDA has observed that your website offers \u201cNicotina Energy Citrus Surge Lite 3 MG\u201d and",0,[16,18,20],"3041523014","",""],["2026-02-05","Bio-Medical Pharmaceutical Manufacturing Corporation",0,6,"","Mr. Yanzhuan Zheng","bio-medical-pharmaceutical-manufacturing-corporation-719654-02052026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Bio-Medical Pharmaceutical Manufacturing Corporation (Bio-Medical), FEI 1650090, at 4311 South Drive, Houston, from August 25 to 29, 2025. This warning letter summ",0,[1,2,3,4,18],"1650090","",""],["2026-02-02","Apollo Care, LLC",0,0,"","James Krogman","apollo-care-llc-715955-02022026","You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. \u00a7 353b] 1 on September 14, 2017, and most recently on December 24, 2025. F",0,[1,2,4,8,15,17,18,21],"3013927023","",""],["2026-02-02","Bertrand P. Cole, D.O.",0,0,"","Bertrand P. Cole, D.O.","bertrand-p-cole-do-723495-02022026","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between May 12 and May 16, 2025. The investigator representing FDA reviewed your conduct of the f",0,[9],"","",""],["2026-02-02","Mark S. Dacey, M.D.",0,0,"","","mark-s-dacey-md-722942-02022026","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between October 23 and November 8, 2024. The investigator representing FDA reviewed your conduct",0,[9],"3031610524","",""],["2026-02-02","Stream2Sea, LLC",0,6,"","Ms. Autumn P. Blum","stream2sea-llc-718983-02022026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Stream2Sea, LLC, FEI 3015234524, located at 2498 Commerce Ct., Bowling Green, FL, from July 9 to 15, 2025. This warning letter summarizes significant violations of",0,[3,13,14,18],"3015234524","",""],["2026-01-30","Cohance Lifesciences Limited",0,0,"","Dr. Vetukuri Venkata Naga Kali Vara Prasada Raju","cohance-lifesciences-limited-718812-01302026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Cohance Lifesciences Limited, FEI 3008768274, at Plot No. A-19/C, A-23A, A-23B, Road No. 18, IDA Nacharam, Uppal Mandal, Medchal-Malkajgiri, from August 4 to Augus",0,[3,6,7,10,14,18],"3008768274","",""],["2026-01-29","Central Coast Multispecialty Medical Group, Inc.",1,4,"","Edward J. Ramirez, MD, FACOG","central-coast-multispecialty-medical-group-inc-722521-01292026","During an inspection of your firm, Central Coast Multispecialty Medical Group, Inc., located at 9833 Blue Larkspur Lane, Monterey, CA, conducted between May 13, 2025, and May 16, 2025, the United States Food and Drug Administration (FDA) documented significant",0,[],"3003969216","",""],["2026-01-29","Diasol, Inc.",2,2,"","Monica F. Abeles","diasol-inc-719460-01292026","During an inspection of your firm located in Phoenix, AZ from July 21, 2025, through August 19, 2025, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures disinfectants used to disinfect dialysate deliv",0,[3,4,8,17,18,20],"3007137482","",""],["2026-01-28","Beta Bionics, Inc.",2,2,"","Sean Saint","beta-bionics-inc-717927-01282026","During an inspection of your firm located in Irvine, CA from June 9, 2025, through June 26, 2025, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the iLet Dosing Decision Software and the iLet ACE",0,[4,9,10,11,18],"3019004087","",""],["2026-01-28","Beta Bionics, Inc.",2,2,"","Sean Saint","beta-bionics-inc-717927-01282026-0","During an inspection of your firm located in Irvine, CA from June 9, 2025, through June 26, 2025, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the iLet Dosing Decision Software and the iLet ACE",0,[4,9,10,11,18],"","",""],["2026-01-27","Conceive Fertility Center",1,4,"","Dr. Derek A. Haas","conceive-fertility-center-722459-01272026","During an inspection of your firm, Conceive Fertility Center located at 7515 Greenville Ave Ste 1030, Dallas, TX 75231, conducted between June 6, 2025, and June 13, 2025, the United States Food and Drug Administration (FDA) documented significant violations fr",0,[],"3014721365","",""],["2026-01-27","Flextronics America LLC",2,2,"","Mr. Vincent Madhavan","flextronics-america-llc-722180-01272026","",0,[4,9,18,20],"3006537560","",""],["2026-01-27","HTO Nevada, Inc. dba Kirkman",0,6,"","Mr. Eric Jon Gripentrog","hto-nevada-inc-dba-kirkman-719074-01272026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, HTO Nevada, Inc. dba Kirkman, FEI 3004268965, at 6400 Rosewood Street, Lake Oswego, from August 18 to 22, 2025. This warning letter summarizes significant violatio",0,[4,5,6,14,15,18],"3004268965","",""],["2026-01-26","Eurosirel S.P.A",0,0,"","Mr. Matteo Scarpis","eurosirel-spa-690733-01262026","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-25-17 dated November 20, 2024. Based on our evaluation, it appears that you have addressed the violations contained in th",0,[],"3015892095","",""],["2026-01-23","Abbott Diabetes Care, Inc.",2,2,"","Christopher Scoggins","abbott-diabetes-care-inc-722046-01232026","During an inspection of your firm located at 1360 S. Loop Rd, Alameda, CA 94502-7000, FEI #3002803444, on October 14, 2025, through October 23, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactur",0,[2,12,18,20],"3002803444","",""],["2026-01-23","Louisville Reproductive Center",1,4,"","Dr. Miriam S. Krause","louisville-reproductive-center-722350-01232026","During an inspection of your firm, Louisville Reproductive Center located at 4123 Dutchmans Lane, Suite 416, Louisville, KY, conducted between April 23, 2025, and April 28, 2025, the United States Food and Drug Administration (FDA) documented significant viola",0,[],"3005081370","",""],["2026-01-21","Signature Formulations, LLC",0,6,"","Ms. Maria Esparza","signature-formulations-llc-718093-01212026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Signature Formulations LLC., FEI 3011368010, at 5446 W Roosevelt St., Ste 101., Phoenix, from July 21 to 29, 2025. This warning letter summarizes significant viola",0,[3,14,18],"3011368010","",""],["2026-01-20","GenoGenix LLC",0,0,"","Samuel Miron","genogenix-llc-718739-01202026","You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. \u00a7 353b] 1 on February 4, 2025. From July 14, 2025, to July 18, 2025, FDA i",0,[1,2,3,8,11,14,16,17,18,21],"3032144832","",""],["2026-01-16","Boothwyn Pharmacy, LLC",0,0,"","John Howell","boothwyn-pharmacy-llc-717525-01162026","From May 12, 2025, to June 9, 2025, U.S. Food and Drug Administration (FDA) investigators inspected your facility, Boothwyn Pharmacy, LLC, located at 221 Gale Lane, Kennett Square, PA 19348. During the inspection, the investigators noted serious deficiencies i",0,[1,2,7,8,17,18,21],"1000076625","",""],["2026-01-14","Fulijaya Manufacturing SDN. BHD.",0,6,"","Mr. Soo Nam Tan","fulijaya-manufacturing-sdn-bhd-719172-01142026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Fulijaya Manufacturing SDN. BHD., FEI 1000291174, at No. 30, Loring Makmur 13/1, Taman Makmur Industrial Estate, Kulim, Kedah, from July 14 to 18, 2025. This warni",0,[0,6,14,18],"1000291174","",""],["2026-01-13","Center For Immunology Science, LLC",0,0,"","Bruce S. Gillis, M.D., MPH","center-immunology-science-llc-719933-01132026","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted between October 7 and November 20, 2024. The investigator representing FDA reviewed the role of the Center for Immunolo",0,[9,20],"3031815667","",""],["2026-01-09","Germaphobix",1,4,"","Jon Tavarez","germaphobix-720555-01092026","The United States Food and Drug Administration (FDA or the Agency) has learned that your firm, Germaphobix, is offering for sale in the United States a human immunodeficiency virus (HIV) serological diagnostic dried blood spot (DBS) card self-collection kit (h",0,[17,18,20],"3036047763","",""],["2026-01-08","Genetrace",1,4,"","","genetrace-720529-01082026","",0,[17,18,20],"3036047667","",""],["2026-01-08","Genovate",1,4,"","","genovate-720554-01082026","",0,[17,18,20],"3036047692","",""],["2026-01-08","Prodrome Sciences USA, LLC",0,0,"","Dayan B. Goodenowe, Ph.D.","prodrome-sciences-usa-llc-717959-01082026","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted between December 17, 2024, and January 10, 2025. The investigator representing FDA reviewed the role of Prodrome Scienc",0,[9],"3016602578","",""],["2026-01-08","Unomedical Device S.A. de C.V.",2,2,"","Daihanna Pe\u00f1a","unomedical-device-sa-de-cv-719428-01082026","During a Remote Regulatory Assessment of your firm located in Reynosa, Tamaulipas, Mexico from July 23, 2025 through August 8, 2025, an investigator from the United States Food and Drug Administration (FDA), reviewed the records you submitted in response to ou",0,[5,9,10,11,18],"3003442380","",""],["2026-01-07","Winder Laboratories, LLC",0,0,"","Steven F. Pressman","winder-laboratories-llc-718601-01072026","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Winder Laboratories, LLC, FEI 3008694072, at 716 Patrick Industrial Lane, Winder, Georgia, from July 14 to August 5, 2025. This warning letter summarizes significa",0,[3,14,18],"3008694072","",""],["2025-12-30","Absolutely Natural",0,6,"","Mr. Daniel Richards","absolutely-natural-715690-12302025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Absolutely Natural, FEI 3004606446, at 640 Atlantis Road, Melbourne, from April 22 to 24, 2025. This warning letter summarizes significant violations of Current Go",0,[5,7,13,14,17,18],"3004606446","",""],["2025-12-23","Chemspec Chemicals Private Limited",0,0,"","Mr. Rushabh Vora","chemspec-chemicals-private-limited-718403-12232025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Chemspec Chemicals Private Limited, FEI 3004947391, located at Plot 3-C, Taluka Panvel, Navi Mumbai, Maharashtra, from July 28, 2025, to August 1, 2025. This warni",0,[0,14,15,18],"3004947391","",""],["2025-12-23","Tower Laboratories Ltd.",0,6,"","Mr. Norman Needleman","tower-laboratories-ltd-717456-12232025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Tower Laboratories Ltd., FEI 1823985, at 8060 Whitbeck Road, Montague, from July 8 to 11, 2025. This warning letter summarizes significant violations of Current Go",0,[5,7,14,18],"1823985","",""],["2025-12-22","Meridian Bioscience, Inc",2,2,"","Tony Serafini-Lamanna","meridian-bioscience-inc-720826-12222025","During an inspection of your firm, Magellan Diagnostics, Inc. located in North Billerica, MA from August 5, 2025, through August 26, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures in-vitro",0,[5,9,11,12,17,18,20,21],"1218996","",""],["2025-12-22","Purushothaman Damodara Kumaran, M.D. / Senthil Specialty Hospital",0,0,"","","purushothaman-damodara-kumaran-md-senthil-specialty-hospital-721325-12222025","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at Senthil Specialty Hospital in Pondicherry, Puducherry, India, between January 20 and 24, 2025. The investigator repr",0,[],"3032031390","",""],["2025-12-19","Agebox Inc.",0,0,"","Wang Zheng","agebox-inc-718252-12192025","",0,[16,17,21],"3038759360","",""],["2025-12-19","Exactech, Inc. dba Advita Ortho",2,2,"","Aurelio Sahagun","exactech-inc-dba-advita-ortho-720250-12192025","During an inspection of your firm located in Sarasota, Florida from July 15, 2025, through July 25, 2025, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Equinoxe Reverse Shoulder Compression S",1,[4,8,9,13,18],"3008658204","",""],["2025-12-19","LiquidCapsule Manufacturing, LLC",0,6,"","Mr. Frederick H. Miller","liquidcapsule-manufacturing-llc-717069-12192025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, LiquidCapsule Manufacturing, LLC, FEI 3006676534, at 9216 Palm River Road, Suite 203, Tampa, Florida, from June 25 to July 3, 2025. This warning letter summarizes",0,[4,5,6,13,15,18],"3006676534","",""],["2025-12-19","Unipack LLC",0,0,"","Mr. Dinesh Patel","unipack-llc-716621-12192025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Unipack LLC, FEI 3008275696, at 111 Coolidge St., South Plainfield, NJ 07080-3801, from June 11 to June 30, 2025. This warning letter summarizes significant violat",0,[0,6,7,14,18],"3008275696","",""],["2025-12-19","Walgreen Company",0,0,"","Jessica Martinez","walgreen-company-662158-12192025","",0,[],"1460851","",""],["2025-12-18","Private Label Skin Care, Inc.",0,0,"","Mr. Samuel D. Raoof","private-label-skin-care-inc-715880-12182025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Private Label Skin Care, Inc., FEI 3015274499, at 8200 Remmet Ave., Canoga Park, CA, from June 16 to 23, 2025. This warning letter summarizes significant violation",0,[6,14,17,18],"3015274499","",""],["2025-12-17","MAST Biosurgery USA, Inc.",2,2,"","Mr. Lukas Bluecher","mast-biosurgery-usa-inc-720661-12172025","During an inspection of your firm located in Irvine, CA from August 18, 2025 through August 21, 2025, an investigator (or investigators) from the United States Food and Drug Administration (FDA) determined that your firm manufactures surgical polymeric mesh de",0,[10,11,17,18,20],"3004661493","",""],["2025-12-16","Early to Bed, Inc.",2,2,"","Searah Deysach","early-bed-inc-720822-12162025","The United States Food and Drug Administration (FDA) has reviewed Early to Bed, Inc.\u2019s (\u201cyour firm\u201d) website (early2bed.com) and observed that your website offers various breast binders for sale. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act",0,[17],"3003879277","",""],["2025-12-16","FLAVNT Streetwear, LLC",2,2,"","Christopher Rhodes","flavnt-streetwear-llc-720838-12162025","The United States Food and Drug Administration (FDA) has reviewed FLAVNT Streetwear, LLC\u2019s (\u201cyour firm\u201d) website (flavnt.com) and observed that your website offers various breast binders for sale. Under section 201(h) of the Federal Food, Drug, and Cosmetic Ac",0,[17],"3042194473","",""],["2025-12-16","Flux Lab Pte. Ltd. d/b/a The Fluxion",2,2,"","Yan Nie","flux-lab-pte-ltd-dba-fluxion-720847-12162025","The United States Food and Drug Administration (FDA) has reviewed Flux Lab Pte. Ltd. d/b/a The Fluxion\u2019s (\u201cyour firm\u201d) website (thefluxion.com) and observed that your website offers various breast binders for sale. Under section 201(h) of the Federal Food, Dru",0,[17],"3042197030","",""],["2025-12-16","GenderBender LLC",2,2,"","Xandar Shephard","genderbender-llc-720842-12162025","The United States Food and Drug Administration (FDA) has reviewed GenderBender LLC\u2019s (\u201cyour firm\u201d) website (genderbenderllc.com) and observed that your website offers various breast binders for sale. Under section 201(h) of the Federal Food, Drug, and Cosmetic",0,[17],"3042194571","",""],["2025-12-16","Guangdong Renhe Guozhuang Biotechnology Co., Ltd.",0,6,"","Mr. Zhou Yigang","guangdong-renhe-guozhuang-biotechnology-co-ltd-719045-12162025","",0,[4,13,18],"3030384816","",""],["2025-12-16","Marli Washington Design, LLC",2,2,"","Marli Washington","marli-washington-design-llc-720840-12162025","The United States Food and Drug Administration (FDA) has reviewed Marli Washington Design, LLC d/b/a gc2b\u2019s (\u201cyour firm\u201d) website (gc2b.co) and observed that your website offers various breast binders for sale. Under section 201(h) of the Federal Food, Drug, a",0,[17],"3042193199","",""],["2025-12-16","Philadelphia 7, Inc d/b/a Passional Boutique",2,2,"","Dumesh Kankanamalage","philadelphia-7-inc-dba-passional-boutique-720843-12162025","The United States Food and Drug Administration (FDA) has reviewed Philadelphia 7, Inc.\u2019s (\u201cyour firm\u201d) website (passionalboutique.com) and observed that your website offers various breast binders for sale. Under section 201(h) of the Federal Food, Drug, and Co",0,[17],"3042194976","",""],["2025-12-16","ShapeShifter Apparel, LLC",2,2,"","Eli Coughlin-Galbraith","shapeshifter-apparel-llc-720845-12162025","The United States Food and Drug Administration (FDA) has reviewed Shapeshifters Apparel LLC\u2019s (\u201cyour firm\u201d) website (shapeshifters.co) and observed that your website offers various breast binders for sale. Under section 201(h) of the Federal Food, Drug, and Co",0,[17],"3042194591","",""],["2025-12-16","TG Supply LLC d/b/a TransGuy Supply",2,2,"","Anthony Guajardo","tg-supply-llc-dba-transguy-supply-720846-12162025","The United States Food and Drug Administration (FDA) has reviewed TG Supply LLC d/b/a TransGuy Supply\u2019s (\u201cyour firm\u201d) website (transguysupply.com) and observed that your website offers various breast binders for sale. Under section 201(h) of the Federal Food,",0,[17],"3042197021","",""],["2025-12-16","For Them, Inc.",2,2,"","Kylo Freeman","them-inc-720839-12162025","The United States Food and Drug Administration (FDA) has reviewed For Them, Inc.\u2019s (\u201cyour firm\u201d) website (forthem.com) and observed that your website offers various breast binders for sale. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the",0,[17],"3042194959","",""],["2025-12-16","TomboyX, PBC",2,2,"","Fran Dunaway","tomboyx-pbc-720849-12162025","The United States Food and Drug Administration (FDA) has reviewed TomboyX, PBC\u2019s (\u201cyour firm\u201d) website (tomboyx.com) and observed that your website offers various breast binders for sale. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Ac",0,[17],"3031304636","",""],["2025-12-16","TOMSCOUT",2,2,"","Lim Tong Moi","tomscout-720850-12162025","The United States Food and Drug Administration (FDA) has reviewed TOMSCOUT\u2019s (\u201cyour firm\u201d) website (tomscout.com) and observed that your website offers various breast binders for sale. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act),",0,[17],"3042195147","",""],["2025-12-16","Trans-Missie B.V.",2,2,"","Dana\u00eb Kurvers","trans-missie-bv-720852-12162025","The United States Food and Drug Administration (FDA) has reviewed Trans-Missie B.V. d/b/a UNTAG\u2019s (\u201cyour firm\u201d) website (untag.com) and observed that your website offers various breast binders for sale. Under section 201(h) of the Federal Food, Drug, and Cosme",0,[17],"3042195160","",""],["2025-12-15","Integrity Partners Group",0,6,"","Mr. Darren J. Birkelbach","integrity-partners-group-716953-12152025","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Chemisphere Corporation, FEI 1000158477, at 2101 Clifton Ave., Saint Louis, MO, from June 16 to 24, 2025. This warning letter summarizes significant violations of Current G",0,[3,4,7,13,18],"1000158477","",""],["2025-12-12","Atomix LLC",0,0,"","Andrew Pierce","atomix-llc-719111-12122025","",0,[16],"3041144563","",""],["2025-12-12","Dynamic Health Group dba SARMS AMERICA",0,0,"","","dynamic-health-group-dba-sarms-america-719257-12122025","",0,[16],"3039801312","",""],["2025-12-12","Maria A. Carballosa, M.D.",0,0,"","","maria-carballosa-md-720805-12122025","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at Power MD Clinical Research Institute, Hialeah, Florida, USA, between March 4 and 6, 2025. The investigator represent",0,[],"3017161883","",""],["2025-12-12","MedisourceRx",0,0,"","Daniel D. Hernandez","medisourcerx-717970-12122025","You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. \u00a7 353b] 1 on February 14, 2017, and most recently on December 31, 2024. Fr",0,[11,16,17,21],"3013316698","",""],["2025-12-12","Musclepower Enterprise Ltd. dba MONSTER KING and GE LABS",0,0,"","","musclepower-enterprise-ltd-dba-monster-king-and-ge-labs-719339-12122025","",0,[16,17,18,21],"3037441759","",""],["2025-12-12","Pinnacle Professional Research dba Pinnacle Peptides",0,0,"","","pinnacle-professional-research-dba-pinnacle-peptides-719337-12122025","",0,[16],"3041273978","",""],["2025-12-12","Prime Sports Nutrition",0,0,"","Fernando Arias","prime-sports-nutrition-719433-12122025","",0,[16],"3017499340","",""],["2025-12-12","TITAN SARMS LLC",0,0,"","","titan-sarms-llc-719645-12122025","",0,[16],"3041411118","",""],["2025-12-11","Devalingam Mahalingam, M.D., Ph.D.",0,0,"","","devalingam-mahalingam-md-phd-721145-12112025","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between October 7 and October 18, 2024. The investigators representing FDA reviewed your conduct",0,[9],"3031824073","",""],["2025-12-11","Palamur Biosciences Private Limited",2,2,"","S. Ramamoorthy, Ph.D.","palamur-biosciences-private-limited-708579-12112025","This Warning Letter is to inform you of objectionable conditions observed during the United States Food and Drug Administration (FDA) inspection conducted at Palamur Biosciences Private Limited (PBS) from January 20, 2025, to January 27, 2025, by investigators",0,[9,20],"3018585295","",""],["2025-12-10","Medinatura New Mexico, Inc.",0,0,"","Mr. Clifford Clive","medinatura-new-mexico-inc-716025-12102025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Medinatura New Mexico, Inc., FEI 1626962, at 10421 Research Road SE, Albuquerque, New Mexico, from May 19 to May 23, 2025. This warning letter summarizes significa",0,[3,4,13,18],"1626962","",""],["2025-12-09","ASP Global, LLC. dba Anatomy Supply Partners, LLC.",2,2,"","Doug Shaver","asp-global-llc-dba-anatomy-supply-partners-llc-718444-12092025","During an inspection of your firm located in Austell, Georgia from July 28, 2025, through August 1, 2025, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures Safe-T-Fill Micro Capillary Collection Syst",0,[11,12,13,17,18,20],"3004824601","",""],["2025-12-09","Sklar Personal Care Inc.",0,0,"","Mr. Ross Sklar","sklar-personal-care-inc-716656-12092025","",0,[3,4,13,14,18],"3007953761","",""],["2025-12-08","Darmerica, LLC",0,0,"","Mr. Kyle Hamza","darmerica-llc-716152-12082025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Darmerica, LLC, FEI 3012389174, at 4380 Oakes Road, Suite 800, Davie, from March 3 through 19, 2025. This warning letter summarizes significant violations, includi",0,[6,7,10,13,14,17,18,21],"3012389174","",""],["2025-12-04","3D Imaging Drug Design and Development LLC",0,0,"","Marc S. Berridge, Ph.D.","3d-imaging-drug-design-and-development-llc-716213-12042025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, 3D Imaging Drug Design and Development LLC, FEI 3009143510, at 9015 Carti Way, Little Rock, from June 9 to 13, 2025. This warning letter summarizes significant vio",0,[1,2,3,8,18],"3009143510","",""],["2025-12-03","Centaur Pharmaceuticals Private Ltd.",0,0,"","Santosh Badhe","centaur-pharmaceuticals-private-ltd-651080-12032025","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-23-15 dated June 5, 2023. Based on our evaluation, it appears that you have addressed the deviations contained in this Wa",0,[],"3003973520","",""],["2025-12-03","Green Valley Fertility Partners",1,4,"","Jeffrey Fisch, MD","green-valley-fertility-partners-720249-12032025","During an inspection of your firm, Green Valley Fertility Partners located at 2950 W. Horizon Ridge, Henderson, NV, conducted between May 8, 2025, and May 14, 2025, the United States Food and Drug Administration (FDA) documented significant violations from the",0,[],"3010953558","",""],["2025-12-03","Microvascular Tissue, Inc.",1,4,"","Glen G. Gong, PhD","microvascular-tissue-inc-710860-12032025","The United States Food and Drug Administration (FDA) inspected your facility, located at the above address, between March 31, 2025, and April 8, 2025. During the inspection, FDA documented that your company markets and distributes a product derived from hypode",0,[4,16,18],"3011742679","",""],["2025-12-01","Apothecary Pharma, LLC",0,0,"","Priyanka Rana","apothecary-pharma-llc-717972-12012025","You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. \u00a7 353b] 1 on September 7, 2024, and most recently on January 11, 2025. Fro",1,[1,2,7,9,11,14,15,16,17,18,21],"3032314463","",""],["2025-11-24","CDL Services, Inc. DBA Technichem",0,6,"","Mr. Luis F Salazar","cdl-services-inc-dba-technichem-713877-11242025","The U.S. Food and Drug Administration (FDA) conducted an inspection at CDL Services, Inc. DBA Technichem, FEI 3012112742, located at 3080 E La Jolla Street, Anaheim, CA, from April 7 to 28, 2025. This warning letter summarizes significant violations of Current",0,[4,6,13,14,17,18],"3012112742","",""],["2025-11-17","Distacart Inc.",0,0,"","Venkata Vamsi Krishna Kothuri","distacart-inc-716212-11172025","",0,[16,17,18],"3039322402","",""],["2025-11-17","Handelnine Global, LLC dba Navafresh",0,0,"","Hiren Gaglani","handelnine-global-llc-dba-navafresh-716013-11172025","",0,[16,17,18,21],"3023005071","",""],["2025-11-17","Mahita LLC dba PushMyCart",0,0,"","Mahesh Chada","mahita-llc-dba-pushmycart-716286-11172025","",0,[16,17,18],"3032813400","",""],["2025-11-17","Swift Digital Group LLC dba Swadesii",0,0,"","Neena Chowdary Koganti","swift-digital-group-llc-dba-swadesii-716644-11172025","",0,[16,17,18],"3031929372","",""],["2025-11-17","VarunKart Group LLC dba Organic Wellnesses",0,0,"","","varunkart-group-llc-dba-organic-wellnesses-716154-11172025","",0,[16,17,18],"3039934997","",""],["2025-11-13","123Herbals",0,0,"","Anthony Trinh","123herbals-719198-11132025","",0,[16,17,21],"3017159925","",""],["2025-11-13","Apitoria Pharma Private Limited Unit 1",0,0,"","Dr. Sanjay Chaturvedi","apitoria-pharma-private-limited-unit-1-618091-11132025","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning 320-22-10 dated January 12, 2022. Based on our evaluation, it appears that you have addressed the deviations contained in this Warni",0,[],"3004021253","",""],["2025-11-13","Cdymax India Pharma Private Limited",0,0,"","Ms. Manorama Avinash","cdymax-india-pharma-private-limited-715022-11132025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Cdymax (India) Pharma Private Limited, FEI 3009882550, at 77d & 116/117, KIADB Industrial Area, Jigani, Bangalore, Karnataka, from April 21 to 25, 2025. This warni",0,[5,7,13,14,18],"3009882550","",""],["2025-11-13","Medical Mega",0,0,"","","medical-mega-717840-11132025","",0,[16,17],"3012211642","",""],["2025-11-13","Save Rite Medical",0,6,"","","save-rite-medical-717838-11132025","",0,[16,17],"3019500785","",""],["2025-11-13","Shoplet",0,0,"","Tony Ellison","shoplet-717846-11132025","",0,[16,17],"3007336343","",""],["2025-11-13","Seema International",0,0,"","Mr. Rajesh Chandra Jain","seema-international-716072-11132025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Seema International, FEI 3007016503, at BT-3/211, Phase-1, Mangolpuri Industrial Area, New Delhi, from May 15 to 21, 2025. This warning letter summarizes significa",0,[3,6,13,14,15,18],"3007016503","",""],["2025-11-12","DeVere Manufacturing Inc.",0,0,"","Mr. Randy D. Stevenson","devere-manufacturing-inc-715846-11122025","The United States Food and Drug Administration (FDA) inspected your drug product manufacturing facility, DeVere Manufacturing Inc., FEI 3012088459, at 1923 Beloit Ave., Janesville, WI, from June 2 to 4, 2025. This warning letter summarizes significant violatio",0,[3,4,5,7,13,14,15,18],"3012088459","",""],["2025-11-12","Physitemp Instruments, LLC",2,2,"","Michele J. Cantwell","physitemp-instruments-llc-717394-11122025","During an inspection of your firm located in Clifton, NJ from April 29, 2025 through June 18, 2025, an investigator (or investigators) from the United States Food and Drug Administration (FDA) determined that your firm manufactures Clinical Electronic Thermome",1,[2,4,10,11,18],"2242483","",""],["2025-11-12","Rhyz Analytical Labs",0,0,"","Mr. Glen S. Putnam","rhyz-analytical-labs-715298-11122025","The United States Food and Drug Administration (FDA) inspected your contract testing laboratory, Rhyz Analytical Labs, FEI 3020181366 at 75 West Center Street, Provo, from June 2 to 5, 2025. This warning letter summarizes significant violations of Current Good",0,[7,14,18],"3020181366","",""],["2025-11-12","Sinsin Pharmaceutical Co., Ltd.",0,0,"","Hyun Kwang Dan","sinsin-pharmaceutical-co-ltd-718720-11122025","",0,[16,17],"3002277609","",""],["2025-11-11","Envoy Medical Inc.",2,2,"","Brent T. Lucas","envoy-medical-inc-718762-11112025","During an inspection of your firm located in Saint Paul, MN from June 24, 2025, through July 2, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufacturers the Esteem II Implantable Hearing System. Un",0,[2,9,10,11,12,18,20],"3004007782","",""],["2025-11-10","Verdure Sciences, Inc.",0,0,"","Ajay S. Patel","verdure-sciences-inc-717259-11102025","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted between June 25 and July 12, 2024. The investigators representing FDA reviewed the role of Verdure Sciences, Inc. (Verd",0,[9],"3004375352","",""],["2025-11-07","Wells Pharma of Houston, LLC",0,0,"","Andrew C. Corbin","wells-pharma-houston-llc-713015-11072025","You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. \u00a7 353b] 1 on March 9, 2020, and most recently on November 5, 2024. From Ma",0,[1,2,3,4,8,11,14,16,17,18,21],"3016710931","",""],["2025-11-04","Siddha Flower Essences, LLC., dba Siddha Remedies",0,6,"","Mr. Michael S. Deland","siddha-flower-essences-llc-dba-siddha-remedies-713217-11042025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Siddha Flower Essences, LLC., dba Siddha Remedies, FEI 3014145088, at 2350 Eastman Ave., Suite 107, Oxnard, from April 22 to 29, 2025. This warning letter summariz",0,[2,13,14,15,17,18],"3014145088","",""],["2025-11-03","AceCosm",0,0,"","","acecosm-718610-11032025","",0,[16,17,21],"","",""],["2025-11-03","Aesthetic Essentials Limited",0,0,"","","aesthetic-essentials-limited-718707-11032025","",0,[16,17,21],"","",""],["2025-11-03","CelestaPro",0,0,"","","celestapro-718613-11032025","",0,[16,17,21],"","",""],["2025-11-03","Cosmenic",0,0,"","","cosmenic-718621-11032025","",0,[16,17,21],"","",""],["2025-11-03","COSMO KOREA",0,0,"","","cosmo-korea-11032025","",0,[16,17,21],"","",""],["2025-11-03","Derma Solution",0,0,"","","derma-solution-11032025","",0,[16,17,21],"","",""],["2025-11-03","Dermacare dba Filler Outlet",0,0,"","","dermacare-dba-filler-outlet-718715-11032025","",0,[16,17,21],"","",""],["2025-11-03","Dermax Co., Ltd",0,0,"","","dermax-co-ltd-718712-11032025","",0,[16,17,21],"","",""],["2025-11-03","Elle Pharm",0,0,"","","elle-pharm-718713-11032025","",0,[16,17,21],"","",""],["2025-11-03","Estaderma",0,0,"","","estaderma-718714-11032025","",0,[16,17,21],"","",""],["2025-11-03","Glam Derma",0,0,"","","glam-derma-11032025","",0,[16,17,21],"","",""],["2025-11-03","Glow Nest Beauty",0,0,"","","glow-nest-beauty-718710-11032025","",0,[16,17,21],"","",""],["2025-11-03","Glowface",0,0,"","","glowface-11032025","",0,[16,17,21],"","",""],["2025-11-03","Korean Aesthetic dba Korean Fillers",0,0,"","","korean-aesthetic-dba-korean-fillers-718842-11032025","",0,[16,17,21],"","",""],["2025-11-03","Maypharm",0,0,"","","maypharm-718717-11032025","",0,[16,17,21],"","",""],["2025-11-03","Meamo",0,0,"","","meamo-11032025","",0,[16,17,21],"","",""],["2025-11-03","Miers Laboratories, Ltd",0,0,"","Mr. Andrew Criglington","miers-laboratories-ltd-715378-11032025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Miers Laboratories, Ltd, FEI 3004087508, at 32 Waiu Street, Wainuiomata, Lower Hutt, Wellington, from May 19 to 21, 2025. This warning letter summarizes significan",0,[13,14,18],"3004087508","",""],["2025-11-03","MJS Medicals",0,0,"","","mjs-medicals-11032025","",0,[16,17,21],"","",""],["2025-11-03","Korea Filler Experts",0,0,"","","korea-filler-experts-718706-11032025","",0,[16,17,21],"3041018090","",""],["2025-10-31","Apotex Inc.",0,0,"","Mr. Allan Oberman","apotex-inc-714137-10312025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Apotex Inc., FEI 3001617666, at 380 Elgin Mills Road East, Richmond Hill, from April 28 to May 9, 2025. This warning letter summarizes significant violations of Cu",1,[1,2,3,6,7,8,14,15,18],"3001617666","",""],["2025-10-30","Owen Biosciences, Inc.",0,6,"","Dr. Donald R. Owen","owen-biosciences-inc-710275-10302025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Owen Biosciences, Inc., FEI 1000132299, at 7053 Revenue Drive, Baton Rouge, from March 25 to 27, 2025. This warning letter summarizes significant violations of Cur",0,[6,14,18],"1000132299","",""],["2025-10-29","World Perfumes Inc.",0,0,"","Ms. Ivania S. Gutierrez","world-perfumes-inc-713958-10292025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, World Perfumes Inc., FEI 3009971047, at 2360 NW 150th Street, Opa-Locka, from May 5 to 9, 2025. This warning letter summarizes significant violations of Current Go",0,[2,5,13,14,17,18],"3009971047","",""],["2025-10-28","Hong Qiangxing Shenzhen Electronics Limited",2,2,"","Zhu Shi Hong","hong-qiangxing-shenzhen-electronics-limited-718112-10282025","During an inspection of your firm located in Shenzhen, Guangdong, China, on August 4, 2025, through August 7, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures wrist blood pressure monitors,",0,[9,10,11,12,18],"","",""],["2025-10-27","DermaRite Industries, LLC",0,6,"","Mr. Fabian McCarthy","dermarite-industries-llc-710997-10272025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, DermaRite Industries, LLC, FEI 1000526900, at 7777 West Side Avenue, North Bergen, from March 26 to April 8, 2025. This warning letter summarizes significant viola",0,[0,6,7,13,14,16,17,18],"1000526900","",""],["2025-10-27","IBSPOT.com Inc.",0,0,"","Danielle White","ibspotcom-inc-715657-10272025","This letter concerns your firm\u2019s distribution of \u201cTaoscare Motion Sickness Patch\u201d and \u201cNavabelle Motion Sickness Patches\u201d products that violate the Federal Food, Drug, and Cosmetic Act (the \u201cFD&C Act\u201d). As discussed further below, your firm is responsible for",0,[16,17,21],"3013631863","",""],["2025-10-21","Uriel Pharmacy, Inc.",0,0,"","Mr. Mark S. McKibben","uriel-pharmacy-inc-709977-10212025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Uriel Pharmacy, Inc., FEI 3003813327, at N8464 Sterman Rd., East Troy, from February 25 to March 4, 2025. This warning letter summarizes significant violations of",0,[1,2,13,14,15,16,18],"3003813327","",""],["2025-10-17","Liebel-Flarsheim Company LLC",0,0,"","Mr. James Daniel Bailey","liebel-flarsheim-company-llc-711508-10172025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Liebel-Flarsheim Company LLC (a wholly owned subsidiary of Guerbet America LLC), FEI 1028892, at 8800 Durant Road, Raleigh, from March 25 to April 8, 2025. This wa",1,[2,3,7,8,14,18],"1028892","",""],["2025-10-16","The Tranzonic Companies/Innocore Sales & Marketing Inc.",0,0,"","Mr. Robert Kibbe","tranzonic-companiesinnocore-sales-marketing-inc-712258-10162025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Innocore Sales & Marketing, Inc., FEI 3010034070, located at 399 Woodall Way, Woodstock, N4T 0K9, Ontario, Canada, from April 22 to 25, 2025. This warning letter s",1,[3,6,13,14,15,18],"3010034070","",""],["2025-10-15","onlineotcmeds.com",0,0,"","","onlineotcmedscom-717697-10152025","",0,[16,17,21],"","",""],["2025-10-10","Acme United Corporation",0,0,"","Mr. Walter C. Johnsen","acme-united-corporation-712324-10102025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Acme United Corporation, FEI 3012129555, at 301 Marianne St., Shelton, CT, from March 18 to 28, 2025. This warning letter summarizes significant violations of Curr",1,[2,4,6,7,14,18],"3012129555","",""],["2025-10-10","Foshan Yiying Hygiene Products Co., Ltd.",0,6,"","Mr. Veblen Liang","foshan-yiying-hygiene-products-co-ltd-715548-10102025","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our February 10, 2025, request for records and other info",1,[4,6,13,14,15,18],"3017706051","",""],["2025-10-10","PQ Pharmacy, LLC",0,0,"","Hale N. Dimetry","pq-pharmacy-llc-715795-10102025","You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. \u00a7 353b] 1 on October 29, 2020, and most recently on November 26, 2024. Fro",0,[1,2,4,11,16,17,18,21],"3017374013","",""],["2025-10-10","RNA Bio/Pharma, Incorporated",0,0,"","Ms. Yvonne E. Grose","rna-biopharma-incorporated-713201-10102025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, RNA Bio/Pharma, Incorporated, FEI 3023116, at 19470 Navarre Coulee Road, Chelan, Washington, from April 9 to April 11, 2025. This warning letter summarizes signifi",0,[4,13,18],"3023116","",""],["2025-10-10","Scientific Protein Laboratories, LLC",0,0,"","Ms. Denise Kwiatkowski","scientific-protein-laboratories-llc-712578-10102025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Scientific Protein Laboratories, LLC, FEI 2111173, at 700 East Main Street, Waunakee, from April 21 to May 2, 2025. This warning letter summarizes significant devi",1,[7,14,18],"2111173","",""],["2025-10-09","Melcare Biomedical Pty Ltd",0,6,"","Anthony Moloney","melcare-biomedical-pty-ltd-717968-10092025","This letter is to advise you that on September 10, 2025 the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including your website at the internet address melcare.com where your Optimel Manuka+ Forte Eye Gel and Optimel Manuka+ Dry Eye",0,[16,17],"3010835414","",""],["2025-10-09","Taizhou Kangping Medical Science and Technology Co., Ltd.",0,6,"","Mr. Yuegen Wang","taizhou-kangping-medical-science-and-technology-co-ltd-711081-10092025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Taizhou Kangping Medical Science and Technology Co., Ltd., FEI 3013321339, at Building 3, No 27 Tai\u2019an Road, Hailing Industrial Park, Taizhou City, Jiangsu, China",0,[0,2,4,5,17,18],"3013321339","",""],["2025-10-06","www.usmedschoice.com",0,0,"","","wwwusmedschoicecom-716055-10062025","",1,[16,17,21],"","",""],["2025-10-03","Qianjiang Kingphar Medical Material Co Ltd.",2,2,"","Wang Jun","qianjiang-kingphar-medical-material-co-ltd-716715-10032025","During an inspection of your firm located in Qianjiang, China from June 30, 2025, through July 3, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures surgical masks, wound dressings, sterilizat",1,[2,3,8,18,20],"","",""],["2025-10-02","Contec Medical Systems Co., Ltd.",2,2,"","Kun \u201cJames\u201d Hu","contec-medical-systems-co-ltd-717941-10022025","During an inspection of your firm located in Qinhuangdao, Hebei, China on June 9, 2025 through June 12, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures CMS 8000 Patient Monitor, CMS600P2PLU",1,[9,10,12,17,18,20],"3006979678","",""],["2025-09-30","Allovate Therapeutics, LLC",1,4,"","William Reisacher, MD","allovate-therapeutics-llc-708912-09302025","The United States Food and Drug Administration (FDA) reviewed your brochure at https://ent.weill.cornell.edu/sites/default/files/lifewithoutallergies.pdf (last visited September 2025), which describes Allerdent, an allergenic toothpaste, which you state \u201ccan b",1,[16],"3038216053","",""],["2025-09-30","Guangxi Yulin Pharmaceutical Group Co. Ltd.",0,0,"","Mr. Guo Guorong","guangxi-yulin-pharmaceutical-group-co-ltd-710422-09302025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Guangxi Yulin Pharmaceutical Group Co. Ltd., FEI 1000589993, at 1 Chengzhan Road in Yulin, Guangxi, from March 17 to 21, 2025. This warning letter summarizes signi",1,[0,5,6,18],"1000589993","",""],["2025-09-26","Technological Medical Advancements LLC",2,2,"","Dr. Bruce R. Coren, DVM, MS","technological-medical-advancements-llc-712715-09262025","During an inspection of your firm located in West Palm Beach, Florida from April 9, 2025, through April 21, 2025, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Diowave 250 WLS and Diowave 100",1,[4,9,10,12,13,17,18,20],"3009346095","",""],["2025-09-25","Creative Essences, Inc.",0,6,"","Mr. Alex D. Daliva","creative-essences-inc-710658-09252025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Creative Essences, Inc., FEI 3006349554, at 15320 Cornet St., Santa Fe Springs, from March 19 to 25, 2025. This warning letter summarizes significant violations of",0,[4,7,13,14,16,17,18],"3006349554","",""],["2025-09-25","Natco Pharma Limited",0,0,"","Mr. Sandeep Kumar","natco-pharma-limited-672564-09252025","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-24-32 dated August 8, 2024. Based on our evaluation, it appears that you have addressed the violations contained in this",0,[],"3004540906","",""],["2025-09-25","Naturich Cosmetique Labs",0,6,"","Mr. Prakash C. Purohit","naturich-cosmetique-labs-713565-09252025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Naturich Cosmetique Labs, FEI 3008480436, at 2505 Merritt Drive, Garland, from April 28 to May 2, 2025. This warning letter summarizes significant violations of Cu",1,[2,4,7,13,14,18],"3008480436","",""],["2025-09-24","New Life Medical Services, LLC",1,4,"","Joshua M. Mansavage","new-life-medical-services-llc-711102-09242025","The United States Food and Drug Administration (FDA) inspected your facility, located at the above address, between May 14, 2024, and May 20, 2024. During the inspection, FDA documented that your company sells human products derived from umbilical cord (Restor",1,[16],"3012046550","",""],["2025-09-23","Insung Medical Co. Ltd.",2,2,"","Mr. In-Keum Song","insung-medical-co-ltd-712545-09232025","During an inspection of your firm located in Gangwon, Korea from April 28, 2025, through May 1, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures ANKOR Endobronchial Tube. Under section 201(h",1,[11,17],"","",""],["2025-09-23","Pers\u014dn & Covey, Inc.",0,0,"","Katharine S. Person","person-covey-inc-711191-09232025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Pers\u014dn & Covey, Inc., FEI #2011222, located at 616 Allen Avenue, Glendale, CA 91021, from January 27 to February 6, 2025. This warning letter summarizes significan",1,[0,4,6,7,14,15,16,17,18],"2011222","",""],["2025-09-22","Kath Khemicals LLC",0,0,"","Ms. Treasure Holston","kath-khemicals-llc-711699-09222025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Kath Khemicals LLC, FEI 3000719870, at 51821 Industrial Dr., from March 31 to April 3, 2025. This warning letter summarizes significant violations of Current Good",1,[6,13,14,15,18],"3000719870","",""],["2025-09-22","Revive Rx LLC dba Revive Rx Pharmacy",0,0,"","Aaron M. Schneider","revive-rx-llc-dba-revive-rx-pharmacy-709509-09222025","From January 27, 2025, to February 7, 2025, a U.S. Food and Drug Administration (FDA) investigator inspected your facility, Revive Rx LLC dba Revive Rx Pharmacy, located at 3831 Golf Drive, Suite A, Houston, TX 77018. During the inspection, the investigator no",0,[1,2,8,10,18,21],"3016710945","",""],["2025-09-19","Pamela K. Den Besten, DDS, MS",0,0,"","","pamela-k-den-besten-dds-ms-715245-09192025","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between September 16 and October 15, 2024. Investigator Dustin R. Abaonza, representing FDA, revi",1,[9],"3029839169","",""],["2025-09-18","LifeVac, LLC",2,2,"2026-03-04","Mr. Arthur Lih","lifevac-llc-713455-09182025","The United States Food and Drug Administration (FDA) is aware that your firm is marketing the LifeVac Rescue Suction Device in the United States without marketing authorization, in violation of the Federal Food, Drug, and Cosmetic Act (the Act). The LifeVac Re",1,[18,20],"3011053282","",""],["2025-09-17","BRS Analytical Services, LLC",0,6,"","Ms. Teresa L. Bandrowsky","brs-analytical-services-llc-711133-09172025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility and contract testing laboratory, BRS Analytical Services, LLC, FEI 3023604380, at 11697 Lakeside Crossing Court, St. Louis, from March 10 to 26, 2025. This warning",1,[1,2,3,8,13,14,18],"3023604380","",""],["2025-09-17","Dixon Investments Inc. dba ARI",0,0,"","Mr. John Gordon Dixon","dixon-investments-inc-dba-ari-710087-09172025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Dixon Investments Inc. dba ARI, FEI 1037559, at 2523 South McDonough Road, Orchard Hill, from March 5 to 11, 2025. This warning letter summarizes significant viola",0,[4,6,14,15,16,17,18,21],"1037559","",""],["2025-09-17","Ralph A. DeFronzo, M.D.",0,0,"","Ralph A. DeFronzo, M.D.","ralph-defronzo-md-716773-09172025","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between December 3 and December 6, 2024. Investigator Ruth E. Medcalf, representing FDA, reviewed",1,[],"3002812722","",""],["2025-09-16","Media Networks Sydney Pty. Limited",0,6,"","Mr. Gilad Wielunski","media-networks-sydney-pty-limited-711342-09162025","Your facility was registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products from March 6, 2024, to July 11, 2025. A review of import records showed a shipment of the OTC drug product, Combant",1,[17,18],"3027059496","",""],["2025-09-16","MicroVention Costa Rica S.R.L.",2,2,"","Alberto Meseguer","microvention-costa-rica-srl-643188-09162025","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 643188, dated September 30, 2022). Based on our evaluation, it appears that you have addressed the violation(s) contained in",0,[],"3010079067","",""],["2025-09-16","Stellalife, Inc.",0,0,"","Gennady Sirota","stellalife-inc-712804-09162025","This letter is to advise you that the United States Food and Drug Administration (FDA or Agency) reviewed your website at the internet address www.stellalife.com in July 2025 and has observed that your website offers products for sale in the United States (U.S",1,[16,17,18],"3013141868","",""],["2025-09-16","Turbare Manufacturing",0,0,"","Laura Martin","turbare-manufacturing-713516-09162025","You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. \u00a7 353b] 1 on June 23, 2023, and most recently on January 25, 2025. From Ja",0,[1,2,8,14,15,17,18,21],"3027507354","",""],["2025-09-12","Cellebration LLC",1,4,"","George Kaltner","cellebration-llc-713252-09122025","The United States Food and Drug Administration (FDA) reviewed your company\u2019s website, https://www.cellebration.com/conditions (last visited September 2025), through which your company offers cellular products derived from cord blood for use in the treatment or",1,[],"3032641083","",""],["2025-09-11","Chengdu Brilliant Biopharmaceutical Co., Ltd.",0,0,"","Mr. Zeng Dong","chengdu-brilliant-biopharmaceutical-co-ltd-711330-09112025","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of active pharmaceutical ingredients (APIs). FDA has reviewed the records you submitted in response to our March 12, 2025, request for records and other inf",1,[4,13,18],"3015530591","",""],["2025-09-11","Columbia Cosmetics Manufacturing Inc.",0,0,"","Ms. Rachel Rendel","columbia-cosmetics-manufacturing-inc-710885-09112025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Columbia Cosmetics Manufacturing Inc, FEI 2919184, at 1661 Timothy Dr., San Leandro, CA, from April 7 to 14, 2025. This warning letter summarizes significant viola",1,[4,7,13,14,17,18],"2919184","",""],["2025-09-10","motionpharmacy.com",0,0,"","","motionpharmacycom-715595-09102025","",1,[16,17],"","",""],["2025-09-09","All American Wellness",0,0,"","","all-american-wellness-715991-09092025","",0,[16,17],"3039843184","",""],["2025-09-09","Alora Pharmaceuticals",0,0,"","Harold A. Deas","alora-pharmaceuticals-716591-09092025","The U.S. Food and Drug Administration (FDA) has reviewed the promotional communications, Alora Pharmaceuticals, LLC\u2019s (Alora) sponsored links 1 2 (3342-v2.1) for RELEXXII\u00ae (methylphenidate hydrochloride extended-release tablets) for oral use, CII (Relexxii), s",0,[17],"3036012598","",""],["2025-09-09","Amazing Meds",0,0,"","","amazing-meds-715506-09092025","",0,[16,17,21],"3039604768","",""],["2025-09-09","ASN-LABS",0,0,"","","asn-labs-716459-09092025","",0,[16,17,21],"3040124832","",""],["2025-09-09","Aytu Biopharma",0,0,"","Josh Disbrow","aytu-biopharma-716599-09092025","As part of its monitoring and surveillance program, the U.S. Food and Drug Administration (FDA) has reviewed the promotional communications, Aytu Biopharma\u2019s (Aytu) sponsored links 1 for ADZENYS XR-ODT (amphetamine) extended-release orally disintegrating table",0,[17],"3016571082","",""],["2025-09-09","Aytu Biopharma",0,0,"","Josh Disbrow","aytu-biopharma-716604-09092025","As part of its monitoring and surveillance program, the U.S. Food and Drug Administration (FDA) has reviewed the promotional communications, Aytu Biopharma\u2019s (Aytu) sponsored links 1 for COTEMPLA XR-ODT (methylphenidate extended-release orally disintegrating t",0,[17],"3016571082","",""],["2025-09-09","Biopreventative Company LLC dba Biopreventative",0,0,"","","biopreventative-company-llc-dba-biopreventative-715505-09092025","",1,[16,17],"3039603932","",""],["2025-09-09","Bioverse, Inc. dba Bioverse",0,0,"","","bioverse-inc-dba-bioverse-716508-09092025","",1,[16,17],"3040107827","",""],["2025-09-09","Body Good Studio",0,0,"","","body-good-studio-716460-09092025","",0,[16,17],"3040123382","",""],["2025-09-09","Canada Med Stop",0,0,"","","canada-med-stop-716517-09092025","",0,[16,17],"3040131489","",""],["2025-09-09","Cosmo Medical Spa dba Cosmo Med Spa",0,0,"","","cosmo-medical-spa-dba-cosmo-med-spa-715873-09092025","",0,[16,17],"3039697671","",""],["2025-09-09","CSL Behring",1,5,"","Kim Aubrey-Larcinese","csl-behring-716297-09092025","The U.S. Food and Drug Administration (FDA) has reviewed the Direct-to-Consumer broadcast advertisement (DTC TV ad), Live in Strength: Supermarket (USA-HIZ-0963), submitted at time of first use by CSL Behring (CSL) for HIZENTRA (Immune Globulin Subcutaneous (H",0,[1,17],"3000215763","",""],["2025-09-09","Curex",0,0,"","","curex-716821-09092025","",0,[16,17],"3016720642","",""],["2025-09-09","Dermacare LLC dba BlueChew",0,0,"","","dermacare-llc-dba-bluechew-716698-09092025","",0,[16,17],"3035557420","",""],["2025-09-09","directmeds.com, Inc. dba DirectMeds",0,0,"","","directmedscom-inc-dba-directmeds-716822-09092025","",0,[16,17],"3016637263","",""],["2025-09-09","Dr. Gater\u2019s Weight Loss & Wellness",0,0,"","Dr. Jameelah Gater, MD","dr-gaters-weight-loss-wellness-712866-09092025","",0,[16,17],"3038967585","",""],["2025-09-09","EA WORKS Limited Liability Company dba Trust Labs",0,0,"","","ea-works-limited-liability-company-dba-trust-labs-715798-09092025","",0,[16,17,21],"3039695059","",""],["2025-09-09","eDrugstore",0,0,"","","edrugstore-716505-09092025","",0,[16,17],"3040107411","",""],["2025-09-09","Elevate Your Wellness LLC, dba Elevated",0,0,"","","elevate-your-wellness-llc-dba-elevated-719811-09092025","",0,[16,17],"3041550128","",""],["2025-09-09","Eli Lilly and Company",0,0,"","David A. Ricks","eli-lilly-and-company-716462-09092025","The U.S. Food and Drug Administration (FDA) has reviewed a promotional communication, a direct-to-consumer online video (video) of an interview featuring representatives from Eli Lilly and Company (Eli Lilly) and a corresponding reporter asking questions regar",0,[17],"1819470","",""],["2025-09-09","Eli Lilly and Company",0,0,"","David A. Ricks","eli-lilly-and-company-716475-09092025","The U.S. Food and Drug Administration (FDA) has reviewed the promotional communication, a direct-to-consumer online video (video) of an interview featuring representatives from Eli Lilly and Company (Eli Lilly) and a corresponding reporter asking questions reg",0,[17],"1819470","",""],["2025-09-09","Eli Lilly and Company",0,0,"","David A. Ricks","eli-lilly-and-company-716485-09092025","The U.S. Food and Drug Administration (FDA) has reviewed the promotional communication, a direct-to-consumer video (video), titled \u201cAn Oprah Special: Shame, Blame, and the Weight Loss Revolution,\u201d regarding ZEPBOUND\u00ae (tirzepatide) injection, for subcutaneous u",0,[17],"1819470","",""],["2025-09-09","Elite Health Center",0,0,"","","elite-health-center-715869-09092025","",0,[16,17],"3016331615","",""],["2025-09-09","EvoLife Wellness",0,0,"","","evolife-wellness-715507-09092025","",0,[16,17],"3039603915","",""],["2025-09-09","Expert Aesthetics",0,0,"","Brenda Burr RN, MSN","expert-aesthetics-715796-09092025","",0,[16,17],"3039695041","",""],["2025-09-09","Fancy Meds, LLC dba Fancy Meds",0,0,"","","fancy-meds-llc-dba-fancy-meds-716487-09092025","",0,[16,17],"3039631641","",""],["2025-09-09","FitRX, LLC dba Zealthy",0,0,"","","fitrx-llc-dba-zealthy-716501-09092025","",0,[16,17],"3040107805","",""],["2025-09-09","FWD Care, Inc. dba FWD",0,0,"","","fwd-care-inc-dba-fwd-716696-09092025","",1,[16,17],"3040268630","",""],["2025-09-09","GenLabMeds",0,0,"","","genlabmeds-713650-09092025","",0,[16,17,21],"3039116118","",""],["2025-09-09","Get.Fit.Medical, LLC dba Get.Fit.Medical",0,0,"","","getfitmedical-llc-dba-getfitmedical-715801-09092025","",1,[16,17],"3039693488","",""],["2025-09-09","GLP-1 Solution",0,0,"","","glp-1-solution-715883-09092025","",0,[16,17,21],"3039699528","",""],["2025-09-09","The HCG Institute",0,0,"","","hcg-institute-716512-09092025","",0,[16,17],"3040107385","",""],["2025-09-09","HealBerry",0,0,"","","healberry-719809-09092025","",1,[16,17],"3041550129","",""],["2025-09-09","Healthon Inc. dba Healthon",0,0,"","Dr. Rasoul M. Montazeri, M.D.","healthon-inc-dba-healthon-719809-09092025","",0,[16,17],"3041550129","",""],["2025-09-09","Healthy Living Clinic",0,0,"","","healthy-living-clinic-09092025","",0,[16,17],"","",""],["2025-09-09","Healthy Male",0,0,"","","healthy-male-716506-09092025","",0,[16,17],"3040107844","",""],["2025-09-09","Hello Cake, Inc. dba Hello Cake",0,0,"","","hello-cake-inc-dba-hello-cake-716484-09092025","",1,[16,17],"3040123384","",""],["2025-09-09","Hims & Hers Health, Inc. dba Hers",0,0,"","Andrew Dudum","hims-hers-health-inc-dba-hers-716825-09092025","",0,[16,17],"3018198112","",""],["2025-09-09","Hims & Hers Health, Inc. dba Hims",0,0,"","Andrew Dudum","hims-hers-health-inc-dba-hims-716567-09092025","",0,[16,17],"3018198112","",""],["2025-09-09","inspire.clinic",0,0,"","","inspireclinic-715799-09092025","",1,[16,17],"3039695048","",""],["2025-09-09","Intimate Rose",0,0,"","","intimate-rose-716458-09092025","",0,[16,17],"3040122472","",""],["2025-09-09","Invigorate Med Spa",0,0,"","","invigorate-med-spa-715872-09092025","",0,[16,17],"3039696090","",""],["2025-09-09","iVisitDoc, Inc. dba iVisitDoc",0,0,"","","ivisitdoc-inc-dba-ivisitdoc-716826-09092025","",0,[17],"3040311864","",""],["2025-09-09","JulyMD",0,0,"","","julymd-716828-09092025","",1,[16,17],"3040309727","",""],["2025-09-09","Las Villas Health Care LLC dba Villas Health",0,0,"","","las-villas-health-care-llc-dba-villas-health-716504-09092025","",0,[16,17],"3040106353","",""],["2025-09-09","Lean Dreams LLC dba LeanDreams",0,0,"","","lean-dreams-llc-dba-leandreams-716697-09092025","",0,[16,17],"3040267095","",""],["2025-09-09","Lovely Meds, Inc. dba Lovely Meds",0,0,"","","lovely-meds-inc-dba-lovely-meds-716829-09092025","",0,[16,17],"3040309873","",""],["2025-09-09","Lumimeds",0,0,"","","lumimeds-716510-09092025","",0,[16,17],"3040124920","",""],["2025-09-09","Lyfe Rx",0,0,"","","lyfe-rx-09092025","",0,[16,17],"","",""],["2025-09-09","Mane & Steel, LLC. dba Mane & Steel",0,0,"","","mane-steel-llc-dba-mane-steel-716455-09092025","",0,[16,17],"3040123314","",""],["2025-09-09","Master Pharmaceuticals Group",0,0,"","","master-pharmaceuticals-group-715800-09092025","",1,[16,17],"3039691892","",""],["2025-09-09","Matthew Stern, CEO MyStart Health LLC.",0,0,"","","matthew-stern-ceo-mystart-health-llc-714755-09092025","",0,[16,17],"3039393381","",""],["2025-09-09","MedClub by Dr. Jenn",0,0,"","Dr. Jenn Guthrie, MD","medclub-dr-jenn-712126-09092025","",0,[16,17,21],"3038802182","",""],["2025-09-09","Novo Nordisk Inc.",0,0,"","Maziar Mike Doustdar","novo-nordisk-inc-716495-09092025","The U.S. Food and Drug Administration (FDA) has reviewed the promotional communication, a direct-to-consumer video (video), titled \u201cAn Oprah Special: Shame, Blame, and the Weight Loss Revolution,\u201d regarding WEGOVY (semaglutide) injection, for subcutaneous use",0,[17],"2244771","",""],["2025-09-09","Nuvo Life Health Inc. dba Nuvo Life Health",0,0,"","","nuvo-life-health-inc-dba-nuvo-life-health-715794-09092025","",0,[16,17],"3039691894","",""],["2025-09-09","Remedy Meds",0,0,"","","remedy-meds-716830-09092025","",0,[16,17],"3040311882","",""],["2025-09-09","Reset IV, LLC dba Reset IV",0,0,"","","reset-iv-llc-dba-reset-iv-716488-09092025","",1,[16,17],"3040124899","",""],["2025-09-09","Royal Philips",2,2,"","Roy Jakobs","royal-philips-709948-09092025","The United States Food and Drug Administration (FDA) conducted the following inspections of your firm\u2019s medical device facilities: Philips Ultrasound, LLC, located at 22100 Bothell Everett Highway, Bothell, WA (FEI No. 3019216) (\u201cBothell\u201d), between January 13,",1,[10,11,18],"3019216","",""],["2025-09-09","SemaBio",0,0,"","","semabio-715866-09092025","",0,[16,17],"3039694268","",""],["2025-09-09","SimpleRx",0,0,"","","simplerx-715874-09092025","",0,[16,17],"3039696172","",""],["2025-09-09","Slendid",0,0,"","","slendid-716700-09092025","",1,[16,17],"3040269000","",""],["2025-09-09","Sprout Health Partners LLC dba Sprout Health",0,0,"","","sprout-health-partners-llc-dba-sprout-health-715879-09092025","",1,[16,17],"3039697747","",""],["2025-09-09","Try Nova",0,0,"","","try-nova-716695-09092025","",0,[16,17],"3040267032","",""],["2025-09-09","TRYM Health, Inc. dba TRYM Health",0,0,"","","trym-health-inc-dba-trym-health-716699-09092025","",1,[16,17],"3040274217","",""],["2025-09-09","Tuyo Health, Inc. dba Tuyo Health",0,0,"","","tuyo-health-inc-dba-tuyo-health-716502-09092025","",0,[16,17],"3040106348","",""],["2025-09-09","Vitals RX",0,0,"","","vitals-rx-715868-09092025","",0,[16,17],"3039699071","",""],["2025-09-09","Yangzhou Yulou Paper Products Co., Ltd.",0,0,"","Ms. Ayna Bian","yangzhou-yulou-paper-products-co-ltd-710907-09092025","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our February 10, 2025, request, and subsequent correspond",1,[1,2,4,6,9,10,13,14,18],"3032025702","",""],["2025-09-09","ybycmeds",0,0,"","","ybycmeds-715878-09092025","",0,[16,17],"3039694862","",""],["2025-09-08","PureRawz",0,0,"","Seann Gloss","purerawz-715218-09082025","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address https://purerawz.co in August 2025 and has observed that your website offers products for sale in the United States (U.S.), inc",1,[11,16],"3014096805","",""],["2025-09-04","NuVida Medical LLC",1,4,"","Park Thomas","nuvida-medical-llc-707745-09042025","The United States Food and Drug Administration (FDA) inspected your facility, located at the above address, between February 10, 2025, and February 19, 2025. During the inspection, FDA documented that your company distributes two products derived from human am",1,[16],"3027320971","",""],["2025-09-04","Shirish M. Gadgeel, M.D.",0,0,"","","shirish-m-gadgeel-md-716181-09042025","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between August 5 and August 23, 2024. Investigator Dina A. Tallman, representing FDA, reviewed yo",1,[9],"","",""],["2025-09-04","Somerset Therapeutics Private Limited",0,0,"","Mr. Veerappan Subramanian","somerset-therapeutics-private-limited-711340-09042025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Somerset Therapeutics Private Limited, FEI 3003821988, located at 54/1 Budihal (Boodihal) Village, Nelamangala, Bengaluru, Karnataka, India, from February 10 to 21",1,[1,2,7,8,14,18],"3003821988","",""],["2025-09-03","Avertix Medical, Inc.",2,2,"","Timothy P. Moran","avertix-medical-inc-711080-09032025","During an inspection of your firm located in Eatontown, NJ from February 19, 2025, through March 11, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures The Guardian System, an implantable coro",1,[2,4,9,10,11,13,17,18],"3017374019","",""],["2025-08-27","Amneal Pharmaceuticals, LLC",0,0,"","Mr. Chintu Patel","amneal-pharmaceuticals-llc-709894-08272025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Amneal Pharmaceuticals Private Limited, FEI 3018907202, located at 506 Survey No., near Sachana Kalyanpura Road Palli, Gujarat, India, from March 10 to 19, 2025. T",1,[7,13,14,18],"3018907202","",""],["2025-08-25","Green Vitality dba Gr33n",0,0,"","","green-vitality-dba-gr33n-710151-08252025","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.gr33n.com/ in June 2025. The FDA has observed that your websites offer \u201cJimerito Honey Eye Drops\u201d for sale in the United Sta",1,[16],"3038443705","",""],["2025-08-25","Homeopathic Educational Services dba Homeopathic Family Medicine",0,0,"","Dana Ullman","homeopathic-educational-services-dba-homeopathic-family-medicine-708635-08252025","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://homeopathic.com/ in May 2025. The FDA has observed that your website offers \u201cCineraria Maritima Eye Drops\u201d for sale in the Unite",1,[16,17,18],"3010816564","",""],["2025-08-25","Life Enthusiast Co-op",0,0,"","Martin Pytela","life-enthusiast-co-op-709315-08252025","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.life-enthusiast.com/ in May 2025. The FDA has observed that your website offers \u201cAmazing Colyrio,\u201d \u201cFulvic Eyes,\u201d and \u201cMSM G",1,[16],"3006716716","",""],["2025-08-25","Mel Honey US",0,0,"","Josue Carias","mel-honey-us-709535-08252025","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://melhoney.us/ in June 2025. We have also reviewed your social media account at https://www.instagram.com/melhoney_us, which direc",1,[16],"3038342588","",""],["2025-08-25","My Holistic Honey c/o Shenzhen Qanhai Wanb Express Supply Chain Co., LTD",0,0,"","Bingbing Feng","my-holistic-honey-co-shenzhen-qanhai-wanb-express-supply-chain-co-ltd-712052-08252025","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your product label and your website at the Internet address https://myholistichoney.com/ in July 2025. The FDA has observed that your website offers \u201cHolistic Honey EYE DROP",1,[16],"3038791431","",""],["2025-08-25","The Richline Group, Inc.",2,2,"","David E. Radcliffe","richline-group-inc-712818-08252025","During an inspection of your firm located in Tamarac, FL, from March 24, 2025, through April 16, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Inverness Ear Care Antiseptic, Inverness",1,[4,6,12,17,18,20],"3006749547","",""],["2025-08-25","Supply Center USA",0,0,"","","supply-center-usa-710859-08252025","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://supplycenterusa.com in May 2025. The FDA has observed that your website offers \u201cSimilasan Allergy Eye Relief\u201d (all variations),",1,[16,17,18],"3038555571","",""],["2025-08-25","Trew Balance",0,0,"","Sheelah Golliglee","trew-balance-709880-08252025","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://trewbalance.com/ in May 2025. The FDA has observed that your website offers \u201cTrew Vision CBD Eye Drops\u201d for sale in the United S",1,[16,17,18],"3038384324","",""],["2025-08-22","Wisconsin Pharmacal Company, LLC",0,0,"","Mr. Heath Ashenfelter","wisconsin-pharmacal-company-llc-710329-08222025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Wisconsin Pharmacal Company, LLC, FEI 2124143, at N168 W 22223 Main St., Jackson, WI, from March 3 to 7, 2025. This warning letter summarizes significant violation",1,[0,2,7,8,14,18],"2124143","",""],["2025-08-21","SeniorLife Technologies, Inc.",2,2,"","Ashok Roy","seniorlife-technologies-inc-707021-08212025","During an inspection of your firm located in 1400 112th Ave., Bellevue, WA 98004, FEI #3027535342, from March 24, 2025, through March 26, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Sen",1,[9,10,11,17,18,20],"3027535342","",""],["2025-08-20","Chromatography Institute of America dba Compounder\u2019s International Analytical Laboratory",0,8,"","Mr. Ronald E. Sutton","chromatography-institute-america-dba-compounders-international-analytical-laboratory-708944-08202025","The United States Food and Drug Administration (FDA) inspected your contract testing laboratory, Chromatography Institute of America dba Compounder\u2019s International Analytical Laboratory, FEI 3012069146, at 4760 Castleton Way, Suite A, Castle Rock, Colorado, fr",1,[0,1,2,7,8,9,14,18],"3012069146","",""],["2025-08-20","Hikal Limited",0,0,"","Dr. K Suresh Babu","hikal-limited-709370-08202025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Hikal Limited, FEI 3003560263, at 72 - 82 / A Kiadb Industrial Area, Jigani, Karnataka, 560105, India, from February 3 to February 7, 2025. This warning letter sum",1,[7,10,13,14,18],"3003560263","",""],["2025-08-19","Miach Orthopaedics",2,2,"","Patrick McBrayer","miach-orthopaedics-709827-08192025","During an inspection of your firm located in Westborough, MA from March 31, 2025 through April 23, 2025, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Bridge-Enhanced ACL Restoration (BEAR) I",1,[2,4,9,12,13,18],"3020652309","",""],["2025-08-15","Innate Healthcare Institute",1,4,"","Travis Whitney, NMD, DAASCP, MSc, MSAc","innate-healthcare-institute-695592-08152025","The United States Food and Drug Administration (FDA) reviewed your company\u2019s website at https://innatehealthcare.org (last visited August 2025), through which your company markets \u201cumbilical cord mesenchymal stem cells (UC-MSCs),\u201d which you also describe as \u201cU",1,[17,19,21],"3019826626","",""],["2025-08-15","Platinum Biologics LLC",1,4,"","Beeben Russell","platinum-biologics-llc-705090-08152025","The United States Food and Drug Administration (FDA) reviewed your company\u2019s website at www.platinumbiologics.com/ (last visited August 2025), through which your company sells two umbilical cord derived products, Nano PRP Jelly and Nano Flex, and two exosome p",1,[16,19],"3031264453","",""],["2025-08-11","Anhui Hanbon Daily Chemical Co., Ltd.",0,0,"","Mr. Alex Li","anhui-hanbon-daily-chemical-co-ltd-708903-08112025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Anhui Hanbon Daily Chemical Co., Ltd., FEI 3017153258, at No. 55 Chuangye Avenue, Xinqiao International Industrial Park, Huainan, Anhui, 232221, from February 24 t",1,[4,6,13,14,18],"3017153258","",""],["2025-08-11","Everlaan Organics, Inc. dba Maple Organics",0,6,"","Ms. Rosy Atwal","everlaan-organics-inc-dba-maple-organics-707956-08112025","Your facility was registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our September 4, 2024 request and subsequent corresponde",0,[4,6,13,14,15,16,17,18],"3025798567","",""],["2025-08-11","LeMaitre Vascular, Inc.",2,2,"","Mr. George LeMaitre","lemaitre-vascular-inc-713502-08112025","During an inspection of your firm located in North Brunswick, NJ from March 4, 2025, through April 16, 2025, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures Artegraft Collagen Vascular Grafts. Unde",1,[2,4,8,9,11,17,18,20],"1000121696","",""],["2025-08-06","ABBE Laboratories, Inc.",0,6,"","Mr. Paul A. Iannuzzo","abbe-laboratories-inc-708309-08062025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, ABBE Laboratories, Inc., FEI 3004433842, located at 1095 Route 110, Suite E, F, Farmingdale, New York, from February 24 to 27, 2025. This warning letter summarizes",0,[3,4,7,13,14,15,18],"3004433842","",""],["2025-08-06","Fallien Cosmeceuticals Ltd. dba Fallene Ltd.",0,6,"","Dr. Harry Fallick","fallien-cosmeceuticals-ltd-dba-fallene-ltd-711006-08062025","This letter is to advise you that on May 14th, 2025 the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including your website, https://tizoskin.com/, where your \u201cTiZO\u00ae SHEERFOAM\u2122 Non-Tinted SPF 30 MINERAL SUNSCREEN FOR BODY & FACE\u201d (he",0,[17],"3029967856","",""],["2025-08-06","K & Care Organics",0,6,"","Shirly Gutshtat, CEO","k-care-organics-711000-08062025","This letter is to advise you that on May 14th, 2025 the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including your website https://www.botaobaby.com/, for your \u201cBOTA\u00d3 GROW NATURALLY Kids Mineral Foam Spray\u201d (hereinafter \u201cBOTA\u00d3 Kids",0,[17],"3023102826","",""],["2025-08-06","Kalani AB dba Kalani Sunwear",0,6,"","Anna Xavier","kalani-ab-dba-kalani-sunwear-710998-08062025","This letter is to advise you that on May 7th, 2025 the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including your website, https://kalanisunwear.com/, where your \u201cKalani sunwear SUN MOUSSE SPF 50\u201d drug product is available for purch",0,[16,17],"3038170997","",""],["2025-08-06","Supergoop!",0,6,"","Lisa Sequino","supergoop-711018-08062025","This letter is to advise you that on May 2nd, 2025 the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including your website, http://supergoop.com/, where your \u201cSupergoop! PLAY SPF 50 BODY MOUSSE\u201d drug product is available for purchase",0,[17],"3012427089","",""],["2025-08-06","Vacation Inc.",0,6,"","James Dakota Green","vacation-inc-706039-08062025","This letter is to advise you that on March 5th, 2025 the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including your website, https://www.vacation.inc/, where your \u201cVacation\u00ae Classic WHIP BROAD SPECTRUM SPF 30 SUNSCREEN MOUSSE\u201d and \u201c",0,[17],"3025628002","",""],["2025-08-01","Confer With",0,0,"","Serge Milbank","confer-707691-08012025","This letter concerns your firm's distribution of a drug product to bleach and/or lighten the skin. Vivant True Tone is an unapproved new drug introduced into interstate commerce in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a) and is misbranded",0,[16,17],"3038120014","",""],["2025-08-01","www.usaquickmeds.com",0,0,"","","wwwusaquickmedscom-713312-08012025","",1,[16,17,21],"","",""],["2025-07-30","Les Encres LLC",2,2,"","Stacey R. Reynolds","les-encres-llc-709263-07302025","During an inspection of your firm Les Encres LLC, FEI 3014822674 located at 149 Kelsey Ln Ste 200 B in Lenoir City, Tennessee, on March 14, 2025, through April 1, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that y",1,[9,10,11,17,18,20],"3014822674","",""],["2025-07-30","Uscom Kft",2,2,"","Mr. Robert Phillips","uscom-kft-708491-07302025","During an inspection of your firm located in Boglarka Utca # 17, Street Budapest, Budapest, 1119 Hungary on January 27, 2025, through January 30, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufact",1,[3,9,10,12,17,18,20],"3011382174","",""],["2025-07-29","AlzClipp / UniUni",0,0,"","","alzclipp-uniuni-711274-07292025","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your product labeling, including your website at the Internet address https://www.alzclipp.com/ in July 2025 and has observed that your website offers \u201cAlzClipp\u201d na",1,[16,17],"3030949819","",""],["2025-07-29","cheaptrustedpharmacy.com",0,0,"","","cheaptrustedpharmacycom-705501-07292025","",1,[16,17,21],"","",""],["2025-07-28","Health and Natural Beauty USA Corp.",0,6,"","Dr. Sayed Ibrahim","health-and-natural-beauty-usa-corp-700187-07282025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Health and Natural Beauty USA Corp., FEI 3011061274, at 140 Ethel Rd West, Ste W, Piscataway, New Jersey, from October 9 to 15, 2024. This warning letter summarize",0,[4,6,13,14,15,16,17,18],"3011061274","",""],["2025-07-23","Nikkiso Co, Ltd.",2,2,"","Koichi Kato","nikkiso-co-ltd-613109-07232025","The Food and Drug Administration has completed an evaluation of Nikkiso\u2019s corrective actions in response to our Warning Letter (CMS #613109; dated May 7th, 2021). Based on our evaluation, it appears that you have addressed the violation(s) contained in this Wa",0,[],"3008786333","",""],["2025-07-23","Shiva Analyticals Private Limited",0,0,"","Mr. Nagaraj Ranganathan","shiva-analyticals-private-limited-707857-07232025","The United States Food and Drug Administration (FDA) inspected your contract testing laboratory, Shiva Analyticals (India) Private Limited, FEI 3006192929, located at Plot 24D (P) and 34D KIADB Industrial Area, Hoskote, Bangaluru, Karnataka State, 562114, Indi",1,[0,7,14,18],"3006192929","",""],["2025-07-22","Spectra Therapy, LLC",2,2,"","John J. Stephan","spectra-therapy-llc-698026-07222025","During an inspection of your firm located in Port Huron, MI on September 10, 2024, through September 13, 2024, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures therapeutic heating infrared lamps,",1,[9,11,12,13,17,18,20],"3008539245","",""],["2025-07-21","Onkos Surgical, Inc.",2,2,"","Patrick J. Treacy","onkos-surgical-inc-712573-07212025","During an inspection of your firm located in Parsippany, NJ from February 4, 2025 through April 4, 2025, an investigator (or investigators) from the United States Food and Drug Administration (FDA) determined that your firm is a specification developer of the",1,[2,3,4,9,10,12,13,18],"3013450937","",""],["2025-07-18","Janssen Vaccines Corp., A Johnson & Johnson Company",0,0,"","Mr. John Yi","janssen-vaccines-corp-johnson-johnson-company-713194-07182025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Janssen Vaccines Corp., A Johnson & Johnson Company (Janssen), FEI 3012637764, at 23, Harmony-ro 303beon-gil, Yeonsu-gu, Incheon, from November 11 to 19, 2024. Thi",1,[2,10,14,15,18],"3012637764","",""],["2025-07-18","Kabana Skin Care LLC",0,0,"","Mr. Erik L. Kreider","kabana-skin-care-llc-710232-07182025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Kabana Skin Care LLC, FEI 3015118914, at 685 S Arthur Ave Unit 9b, Louisville, CO 80027-3141, from February 19 to 20, 2025. This warning letter summarizes signific",1,[6,13,14,17,18],"3015118914","",""],["2025-07-18","LEVO AG",2,2,"","Daniel T. Johnson","levo-ag-717287-07182025","During an inspection of your firm located in Wohlen, Switzerland on April 7, 2025, through April 9, 2025, an investigator from the United States (U.S.) Food and Drug Administration (FDA) determined that your firm manufactures the LEVO C3; LEVO Combi; LEVO LAE;",1,[4,9,10,11,12,13,17,18,20],"1000268398","",""],["2025-07-17","Leltek Inc.",2,2,"","Kuo-Ping (Michael) Liu","leltek-inc-710787-07172025","During an inspection of your firm located in New Taipei, Taiwan on March 3, 2025, through March 6, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Ultrasound Imaging System LU700 Series and",0,[10,11,12,13,17,18,20],"3014555455","",""],["2025-07-17","www.mysteroidsmarket.com",0,0,"","","wwwmysteroidsmarketcom-711353-07172025","",0,[16,17,21],"","",""],["2025-07-16","www.d-pharmacy.com",0,0,"","","wwwd-pharmacycom-711075-07162025","",1,[16,17,21],"","",""],["2025-07-16","www.plakini-pharma.com",0,0,"","","wwwplakini-pharmacom-705185-07162025","",0,[16,17,21],"","",""],["2025-07-16","www.portmeds.com",0,0,"","","wwwportmedscom-711585-07162025","",1,[16,17,21],"","",""],["2025-07-15","Oasis Medical, Inc.",0,0,"","Mr. Norman Craig Delgado","oasis-medical-inc-707198-07152025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facilities, Oasis Medical, Inc., FEI 2083373, at 514 S. Vermont Avenue, Glendora, from January 15 to 27, 2025. This warning letter summarizes significant violations of Curre",1,[2,4,5,6,7,14,18],"2083373","",""],["2025-07-14","WHOOP, Inc.",2,2,"","Will Ahmed","whoop-inc-709755-07142025","The United States Food and Drug Administration (FDA) has learned that your firm is marketing Blood Pressure Insights (hereinafter, \"BPI\") in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (Th",0,[17,18,20],"3031627845","",""],["2025-07-11","Glenmark Pharmaceuticals Limited",0,0,"","Mr. Umesh Gupta","glenmark-pharmaceuticals-limited-708270-07112025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Glenmark Pharmaceuticals Limited, FEI 3008565058, located at Phase \u2013 II, Sector III, Plot No 2, Pharma Zone, SEZ, Pithampur, Madhya Pradesh, 454774 India, from Feb",0,[3,4,5,6,7,15,18],"3008565058","",""],["2025-07-11","Jiangsu Kerbio Medical Technology Group Co.",2,2,"","Mr. Shangyou Lin","jiangsu-kerbio-medical-technology-group-co-705188-07112025","This Warning Letter is to inform you of objectionable conditions observed during the United States Food and Drug Administration (FDA) inspection conducted at Jiangsu Kerbio Medical Technology Group Co. from January 15, 2025, to January 24, 2025, by investigato",1,[20],"3031797474","",""],["2025-07-10","Turkuaz Sa\u011flik Hizmetleri Medikal Temizlik Kimyasa",2,2,"","Mehmet Kayaba\u015f","turkuaz-saglik-hizmetleri-medikal-temizlik-kimyasa-649158-07102025","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter, CMS # 649158, dated December 29, 2022. Based on our evaluation, it appears that you have addressed the violations contained in thi",0,[],"3009482034","",""],["2025-07-09","Covalent Medical",0,6,"","Clint Worley, COO","covalent-medical-695839-07092025","This letter is to advise you that on September 27, 2024 the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including on your website at the internet address, www.focusvitamins.com, where your FOCUS PI Post-Injection Eye Drops product i",0,[16,17],"3010869749","",""],["2025-07-09","EyeTech One, LLC",0,6,"","Alvaro E. Arenas, AMBR","eyetech-one-llc-712438-07092025","This letter is to advise you that on September 26, 2024 the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including on your website at the internet address, www.eyelivio.com, where your EYELIVIO lubricant eye ointment product is avail",0,[16,17],"3032071869","",""],["2025-07-09","Gussyup LLC dba Private Label Grooming",0,0,"","Mr. Neal Flowers","gussyup-llc-dba-private-label-grooming-709488-07092025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Gussyup LLC (dba Private Label Grooming), FEI 3029236854, at 7360 Eastgate Rd, Suite 135, Henderson, from February 18 to 20, 2025. This warning letter summarizes s",1,[6,13,14,18],"3029236854","",""],["2025-07-09","Medical Chemical Corporation",0,6,"","Mr. Emmanuel R. Didier","medical-chemical-corporation-706007-07092025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Medical Chemical Corporation, FEI 2013736, at 19430 Van Ness Avenue, Torrance, from February 12 to 18, 2025. This warning letter summarizes significant violations",0,[13,14,15,16,17,18],"2013736","",""],["2025-07-09","Revitalize Energy, Inc.",0,6,"","Kyle Guinness","revitalize-energy-inc-712417-07092025","This letter is to advise you that on April 14, 2025 the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including on your website at the internet address https://myrevitalize.com/ where your Revitalize Energizing Eye Drops drug product",0,[16,17],"3038344092","",""],["2025-07-09","Scope Health Inc",0,6,"","Tom Freyne","scope-health-inc-695085-07092025","This letter is to advise you that on August 28, 2024 the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including on your website at the internet address optase.com where your ophthalmic drug products are available for purchase in the",0,[16,17,21],"3017957591","",""],["2025-07-09","Thea Pharma, Inc.",0,6,"","Susan K. Benton","thea-pharma-inc-712416-07092025","This letter is to advise you that on August 29, 2024 the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including on your website at the internet address www.ivizia.com and your Amazon storefront at https://www.amazon.com/iVIZIA-Lubric",0,[16,17],"3022351866","",""],["2025-07-07","O3UV, LLC",1,4,"","Timothy Lowe","o3uv-llc-668840-07072025","The United States Food and Drug Administration (FDA) inspected your facility located at 11968 Sweetwater Drive, Grand Ledge, MI 48837-8101, between August 23, 2023, and August 31, 2023. During the inspection, FDA documented that your firm manufactures autohemo",0,[9,10,11,12,14,17,18,19,20],"3027918571","",""],["2025-07-02","Daewoo Pharmaceutical Co., Ltd.",0,0,"","Mr. Jin Soo Baek","daewoo-pharmaceutical-co-ltd-706371-07022025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Daewoo Pharmaceuticals Co., Ltd., FEI 1000448124, at 153, Dadae-ro, Saha-gu, Busan, from January 6 to 15, 2025. This warning letter summarizes significant violatio",0,[1,2,7,8,10,13,14,15,18],"1000448124","",""],["2025-07-02","Exela Pharma Sciences, LLC",0,0,"","Phanesh Koneru, PhD, LL.M.","exela-pharma-sciences-llc-709859-07022025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Exela Pharma Sciences, FEI 3008563008, at 1245 Blowing Rock Blvd, Lenoir, NC 28645, from November 4, 2024, to November 15, 2024. This warning letter summarizes sig",1,[0,2,4,6,7,8,14,18,21],"3008563008","",""],["2025-06-27","Libby Laboratories, Inc.",0,0,"","Ms. Susan Carol Libby President","libby-laboratories-inc-708259-06272025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Libby Laboratories, Inc., FEI 2912388, at 1700 Sixth Street, Berkeley, California, from March 11 to 14, 2025. This warning letter summarizes significant violations",1,[13,15,18],"2912388","",""],["2025-06-27","Mectronic Medicale S.R.L.",2,2,"","Ennio Aloisini","mectronic-medicale-srl-707997-06272025","During an inspection of your firm located in Bergamo, Italy from February 24, 2025, through February 27, 2025, an investigator from the United States Food and Drug Administration (FDA, we, or the agency) determined that your firm manufactures CHELT, Ixyon XP,",1,[4,5,11,12,17,18,20],"3015283772","",""],["2025-06-26","Mark J. Savant, M.D",0,0,"","","mark-j-savant-md-712306-06262025","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between April 9 and April 17, 2024. Investigator Dustin R. Abaonza, representing FDA, reviewed yo",0,[9],"3030218581","",""],["2025-06-25","7Tabz Retail, LLC",0,0,"","Jonathan Daye","7tabz-retail-llc-709546-06252025","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address www.pop7tabz.com in May 2025 and has observed that your website offers various products marketed to contain 7-hydroxymitragynin",0,[11,16,18],"3018102311","",""],["2025-06-25","CCIC Huatongwei International Inspection Co., Ltd.",2,2,"","Mr. Xiaojun Su","ccic-huatongwei-international-inspection-co-ltd-704332-06252025","This Warning Letter is to inform you of objectionable conditions observed during the United States Food and Drug Administration (FDA) inspection conducted at CCIC Huatongwei International Inspection (Suzhou) Co., Ltd. from January 6, 2025, to January 14, 2025,",0,[0,9,20],"3031798470","",""],["2025-06-25","Hydroxie, LLC",0,9,"","Tim R. Shaw","hydroxie-llc-709661-06252025","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address www.hydroxie.com in May 2025 and has observed that your website offers various products that appear to contain 7-hydroxymitragy",0,[3,11,16,18,20],"3038292919","",""],["2025-06-25","Nature\u2019s Fusions LLC",0,0,"","Ms. Lori A. Peterson","natures-fusions-llc-707024-06252025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Nature\u2019s Fusions LLC, FEI 3012853845, at 57 North 1380 West, Orem, Utah, from January 15 to 21, 2025. This warning letter summarizes significant violations of Curr",0,[2,6,7,13,18],"3012853845","",""],["2025-06-25","Xtreme Tools International, Inc.",0,0,"","Mr. Ali Mithavayani","xtreme-tools-international-inc-706053-06252025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Xtreme Tools International, Inc., FEI 3010314796, located at 15400 NW 34th Avenue, Opa Locka, from January 27 to 31, 2025. This warning letter summarizes significa",1,[4,10,13,14,17,18],"3010314796","",""],["2025-06-18","Dynamic Blending Specialists, Inc.",0,6,"","Mr. Gavin Victor Collier","dynamic-blending-specialists-inc-701278-06182025","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Dynamic Blending Specialists, Inc., FEI 3013719300, at 523 East 1750 N. Suite 100, Vineyard, Utah 84059-8109, from December 3 to 6, 2024. This warning letter summarizes sig",0,[13,14,15,16,17,18],"3013719300","",""],["2025-06-18","LEC Custom Products, Inc.",0,0,"","Mr. Jeremy Willard","lec-custom-products-inc-607838-06182025","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s remediation in response to our Warning Letter 320-20-47 dated September 24, 2020. Based on our evaluation, it appears that you have addressed the matter by no longer manufacturin",0,[18],"3004737602","",""],["2025-06-18","Peter Michael, M.D.",0,0,"","Peter Michael, M.D.","peter-michael-md-711299-06182025","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between June 3 and June 11, 2024. Investigator Angelica M. Chica, representing FDA, reviewed your",1,[9],"","",""],["2025-06-16","Pushclean Technology Plastik Sanayi Ve Ticaret Ltd. Sirketi",0,0,"","Mr. Sinan Gundogan","pushclean-technology-plastik-sanayi-ve-ticaret-ltd-sirketi-709156-06162025","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our September 4, 2024 request for records and other infor",1,[6,13,14,17,18],"3021033904","",""],["2025-06-13","InVia Fertility Specialists, PLLC",1,4,"","Vishvanath C. Karande","invia-fertility-specialists-pllc-710632-06132025","During an inspection of your firm, InVia Fertility Specialists, PLLC 1585 Barrington Rd Ste 406, Hoffman Estates, IL 60169, conducted between January 28, 2025, and February 5, 2025, the United States Food and Drug Administration (FDA) documented significant vi",1,[],"3004744097","",""],["2025-06-13","Visgeneer, Inc",2,2,"","Dr. Ken-Shwo Dai","visgeneer-inc-709010-06132025","During an inspection of your firm located in Hsinchu City, Taiwan from February 24 through February 27, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the eBchek Blood Glucose Monitoring S",1,[10,11,12,17,18,20],"","",""],["2025-06-13","www.soma4ever.com",0,0,"","","wwwsoma4evercom-706082-06132025","",1,[16,17,21],"","",""],["2025-06-12","Healwell Homeo Private Limited",0,0,"","Mr. Luv Patel","healwell-homeo-private-limited-706206-06122025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Healwell Homeo Private Limited, FEI 3028192440, Plot No. 215/1 220/1 & 221/1, Village Indrad, Tal Kadi, District Mehsana, Ahmedabad, Gujarat, from December 13 to 2",1,[3,13,14,18],"3028192440","",""],["2025-06-12","Kenil Healthcare Private Limited",0,0,"","Mr. Anil Patel","kenil-healthcare-private-limited-704786-06122025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Kenil Healthcare Private Limited, FEI 3022380309, at Plot No. 319, Village Acharasan, Ankhol-Vamaj Road, Tal-Kadi, District Mehsana, Gujarat, from December 5 to 11",1,[0,3,4,6,7,14,15,18],"3022380309","",""],["2025-06-12","www.buynetmeds.com",0,0,"","","wwwbuynetmedscom-706335-06122025","",1,[16,17,21],"","",""],["2025-06-10","www.buyprosoma.com",0,0,"","","wwwbuyprosomacom-705973-06102025","",1,[16,17,21],"","",""],["2025-06-09","Reset Technology Corporation",2,2,"","Mark Teufel","reset-technology-corporation-704828-06092025","During an inspection of your firm located in Englewood Cliffs, NJ, from October 29, 2024, through December 20, 2024, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the ResetSmile Partial Denture",1,[3,4,9,10,11,18],"3030254128","",""],["2025-06-06","Horizon Tool Inc.",0,0,"","Mr. Sean M. Kenny","horizon-tool-inc-706567-06062025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Horizon Tool Inc., FEI 3016555297, at 7918 Industrial Village Rd, Greensboro, from January 14 to 16, 2025. This warning letter summarizes significant violations of",1,[6,13,15,18],"3016555297","",""],["2025-06-05","Sterling Distributors",0,0,"","Mr. Dean Berry","sterling-distributors-706508-06052025","The U.S. Food and Drug Administration (FDA) inspected your wholesale distribution facility, Sterling Distributors (Sterling), FEI 3007309337, 4381 NW 124th Ave, Coral Springs, FL 33065-7634, from March 4, 2025, to March 6, 2025. The Drug Supply Chain Security",1,[],"3007309337","",""],["2025-06-04","Ambu USA",2,2,"","Steven Block","ambu-usa-661617-06042025","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 661617), dated August 16, 2023. Based on our evaluation, it appears that you have addressed the violations contained in this",0,[],"1824226","",""],["2025-06-04","www.bigpharmausa.com",0,0,"","","wwwbigpharmausacom-702681-06042025","",1,[16,17,21],"","",""],["2025-06-03","Insightra Medical Inc.",2,2,"","Kai W. Trompeter","insightra-medical-inc-706921-06032025","During an inspection of your firm located in Clarksville, TN, on January 21, 2025, through January 27, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Double Pump as well as the Ultra I",1,[9,10,11,13,17,18,20],"3003945344","",""],["2025-05-30","Bio Wellness 444 LLC",0,0,"","Kimberly Moody, Co-Owner","bio-wellness-444-llc-709333-05302025","This letter is to advise you that on March 10th, 2025 the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including on your website, biowellness444.com, where your \u201cSilver Bullet elite douche\u201d and \u201cSilver D elite douche\u201d drug products a",0,[16,19],"3033048118","",""],["2025-05-29","Amish Origins Management, LLC",0,6,"","Mr. Joshua V. Hansen","amish-origins-management-llc-704166-05292025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Amish Origins Management, LLC, FEI 3013538760, at 1214 South Flat Road, Worland, from January 7 to 10, 2025. This warning letter summarizes significant violations",0,[7,13,14,15,16,17,18],"3013538760","",""],["2025-05-29","Laboratoire Druide Inc.",0,0,"","Ms. Manon Pilon","laboratoire-druide-inc-705517-05292025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Laboratoires Druide Inc., FEI 3008226137, at 154 Oneida Avenue, Pointe-Claire, Quebec, Canada, from February 10 to 14, 2025. This warning letter summarizes signifi",0,[2,3,4,7,13,15,17,18],"3008226137","",""],["2025-05-22","Medgel Private Limited",0,0,"","Mr. Alok K. Garg","medgel-private-limited-654085-05222025","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-23-17 dated July 20, 2023. Based on our evaluation, it appears that you have addressed the violations contained in this W",0,[],"3010165392","",""],["2025-05-21","Aju Pharm Co., Ltd.",2,2,"","Tae Hoon Kim","aju-pharm-co-ltd-704823-05212025","During an inspection of your firm located in Seongnam-Si, Gyeonggi, South Korea on January 20, 2025, through January 23, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Class II Fixone",1,[9,10,11,12,13,17,18,20],"3014232239","",""],["2025-05-19","CTK OTC Laboratories LLC formerly FMK LABS, Inc.",0,0,"","Daniel Ramirez, General Manager","ctk-otc-laboratories-llc-formerly-fmk-labs-inc-705479-05192025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, CTK OTC Laboratories LLC (formerly FMK LABS, Inc.), FEI 3014253278, at 1690 N Delilah St., Corona, California, from December 16 to 31, 2024. This warning letter su",0,[4,7,14,18],"3014253278","",""],["2025-05-19","Prodose, Inc. formerly known as Spirit Pharmaceuticals LLC",0,0,"","Kunjal Joshi","prodose-inc-formerly-known-spirit-pharmaceuticals-llc-654751-05192025","The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 2851, CMS 654751. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Fu",0,[],"3011773798","",""],["2025-05-14","Evi Labs LLC",0,0,"","Mr. Luis E. Echeverria","evi-labs-llc-705846-05142025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Evi Labs LLC, FEI 3014581785, at 9110 NW 106th Street, Medley, Florida, from January 9 to 15, 2025. This warning letter summarizes significant violations of Curren",0,[4,6,7,14,18],"3014581785","",""],["2025-05-14","Zhejiang Easyclean Daily Chemical Co., Ltd",0,0,"","Alex Hua","zhejiang-easyclean-daily-chemical-co-ltd-702295-05142025","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our March 11, 2024 request, and subsequent correspondence",0,[4,6,15,18],"3016734050","",""],["2025-05-13","AACE Pharmaceuticals, Inc.",0,0,"","Mr. Atul B. Mehta","aace-pharmaceuticals-inc-701310-05132025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, AACE Pharmaceuticals, Inc., FEI 3013433273, at 15 Gardner Road, Fairfield, from November 12 to 22, 2024, after an FDA inspection revealed violative conditions at B",1,[1,2,13,14,18],"3013433273","",""],["2025-05-09","Kabe Labortechnik GmbH",2,2,"","Andre Kolpe","kabe-labortechnik-gmbh-704563-05092025","During an inspection of your firm located in Numbrecht, North Rhine-Westphalia, Germany, on January 6 through 9, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures blood collection tubes inclu",1,[9,10,11,12,17,18,20],"3002807393","",""],["2025-05-09","NeuroSync, Inc.",2,2,"","Gary Gregory","neurosync-inc-705489-05092025","During an inspection of your firm located in Holliston, MA, on January 6, 2025, through February 5, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures EYE-SYNC, consisting of a virtual reality",1,[9,11,12,17,18,20],"3014133165","",""],["2025-05-08","Microspecialties, LLC",2,2,"","Gaston S. Levesque","microspecialties-llc-707614-05082025","During an inspection of your firm located in Middletown, CT, from January 14, 2025, through February 18, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm contract manufactures Class I and II ophthalmic s",1,[2,4,5,18,20],"3002616700","",""],["2025-05-08","Product Society LLC",0,0,"","Mr. Phillip A.S. Miller","product-society-llc-702927-05082025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Product Society LLC, FEI 3023272193, at 13056 Saticoy Street, North Hollywood, CA 91605, from November 18 to 27, 2024. This warning letter summarizes significant v",1,[4,6,13,14,17,18],"3023272193","",""],["2025-05-07","Excelvision Fareva",0,0,"","Mr. Bernard Fraisse","excelvision-fareva-703245-05072025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Excelvision, FEI 3007058211, at 27 Rue de la Lombardiere, Annonay, Ardeche, France, from November 12 to 19, 2024. This warning letter summarizes significant violat",1,[1,2,3,6,8,10,18],"3007058211","",""],["2025-05-06","Amy Lightner MD",1,4,"","Amy Lightner, MD","amy-lightner-md-682593-05062025","The Food and Drug Administration (FDA) has completed an evaluation of your corrective actions in response to our Warning Letter CBER-25-682593 dated March 25, 2025. Based on our evaluation, it appears that you have addressed the violations contained in this Wa",0,[],"3026147808","",""],["2025-05-06","DFI Co., Ltd.",2,2,"","Jeong-Hee Jang","dfi-co-ltd-705464-05062025","",0,[10,11,17,18,20,21],"","",""],["2025-05-06","Shenzhen Hengkaifeng Commerce and Trade Co., Ltd",0,0,"","","shenzhen-hengkaifeng-commerce-and-trade-co-ltd-706318-05062025","",1,[17],"","",""],["2025-05-05","Sedecal S.A.",2,2,"","S. Manuel Martinez Garc\u00eda","sedecal-sa-707156-05052025","During an inspection of your firm located in Madrid, Spain on January 20, 2025, through January 24, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures DX-D 100, DX-D 600, and MobileDiagnost wD",1,[9,10,12,17,18,20],"","",""],["2025-05-05","Staska Pharmaceuticals, Inc.",0,0,"","Lyndon R. Leitner","staska-pharmaceuticals-inc-699291-05052025","You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. \u00a7 353b] 1 on December 3, 2020, and most recently on December 18, 2024. Fro",1,[1,2,4,8,11,16,17,18,21],"3017473850","",""],["2025-05-05","Supreme Rejuvenation, LLC",1,4,"","Aracely Cabrera","supreme-rejuvenation-llc-700749-05052025","The United States Food and Drug Administration (FDA) reviewed your company\u2019s websites at www.supremerejuvenation.com and www.instagram.com/supremeexosomes (last visited May 2025). Your website (www.supremerejuvenation.com) indicates that you sell \u201c100 Billion",1,[16],"3034929505","",""],["2025-05-05","www.buycodeine.us",0,0,"","","wwwbuycodeineus-702527-05052025","",1,[16,17,21],"","",""],["2025-05-05","www.peacefulmeds.com",0,0,"","","wwwpeacefulmedscom-703470-05052025","",1,[16,17,21],"","",""],["2025-05-01","Konrad Rejdak, MD, PhD",1,0,"","Konrad Rejdak, M.D.","konrad-rejdak-md-phd-671405-05012025","The United States Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter CBER 24-671405 dated May 29, 2024. Based on our evaluation, it appears that you have addressed the violations c",0,[],"3025922936","",""],["2025-04-30","American Behavioral Research Institute, LLC",0,0,"","Timea Ciliberti","american-behavioral-research-institute-llc-705629-04302025","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted between April 17 and May 3, 2024. Investigator Sheri L. Stephenson, representing FDA, reviewed the role of American Beh",0,[9],"3030358101","",""],["2025-04-30","Ningbo Riway Industrial Co., Ltd.",0,6,"","Mr. David Duan","ningbo-riway-industrial-co-ltd-692870-04302025","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our March 11, 2024 request for records and other informat",0,[13,14,16,17,18,21],"3016905536","",""],["2025-04-30","Rechon Life Science AB",0,0,"","Mr. Roland Holmqvist","rechon-life-science-ab-701040-04302025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Rechon Life Sciences AB, FEI 3002806978, at Soldattorpsvagen 5, Limhamn, Skane Lan, 216 13, Sweden, from August 26 to September 6, 2024. This warning letter summar",0,[1,2,3,7,8,14,18],"3002806978","",""],["2025-04-28","Nana Barseghian, M.D.",0,0,"","","nana-barseghian-md-708009-04282025","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between February 12 and February 16, 2024. Investigators Jasmine Y. Wang and Cheron M. Portee, re",0,[9],"3029994548","",""],["2025-04-23","OSRX, Inc.",0,0,"","","osrx-inc-701889-04232025","You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. \u00a7 353b] 1 on October 28, 2023, and most recently on October 25, 2024. From",0,[1,2,8,11,15,16,17,18,21],"3014549846","",""],["2025-04-23","www.24hreup.biz",0,0,"","","www24hreupbiz-700358-04232025","",1,[16,17,21],"","",""],["2025-04-17","Amazon.com, Inc.",0,6,"","Andrew R. Jassy","amazoncom-inc-689355-04172025","This letter concerns your firm\u2019s distribution of products that violate the Federal Food, Drug, and Cosmetic Act (the \u201cFD&C Act\u201d). The United States Food and Drug Administration (FDA) purchased on your website, www.amazon.com, external analgesic drug products i",0,[16,17],"3016994737","",""],["2025-04-16","Mentha & Allied Products Private Ltd.",0,0,"","Mr. Arvind Nanda","mentha-allied-products-private-ltd-700242-04162025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Mentha & Allied Products Private Ltd., FEI 3004293613, located at 16th Km Rampur-Swar Road, Rampur, Uttar Pradesh, India, from September 16 to 25, 2024. This warni",0,[0,3,4,5,6,14,15,18],"3004293613","",""],["2025-04-15","Shantou S.E.Z. Baojie Industry Co., Ltd.",0,0,"","Mr. WuXiong Wu","shantou-sez-baojie-industry-co-ltd-703439-04152025","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Shantou S.E.Z. Baojie Industry Co., Ltd., FEI 3016787260, at Sihuang Road Lugang Town, Chaonan District, Shantou, Guangdong, China, from August 26 to 30, 2024. This warning",0,[6,13,14,17,18],"3016787260","",""],["2025-04-14","Cosco International, Inc.",0,6,"","Mr. Peter M. Hoffman","cosco-international-inc-701209-04142025","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Cosco International Inc, FEI 3000220439, at 1633 Sands Pl SE. Marietta, from October 15th to 25th 2024. This warning letter summarizes significant violations of Current Goo",0,[0,3,4,6,14,16,17,18,21],"3000220439","",""],["2025-04-09","BEO Pharma Inc. dba BEO Pharmaceuticals Inc.",0,0,"","Ms. Amanda S. Ambrose","beo-pharma-inc-dba-beo-pharmaceuticals-inc-701364-04092025","",0,[4,5,13,14,18],"3027036172","",""],["2025-04-09","Dyno Manufacturing, Inc.",0,0,"","Ms. Jennifer A. Boofer","dyno-manufacturing-inc-700785-04092025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Dyno Manufacturing, Inc., FEI 3017219182, at 2 Fox Industrial Dr., Madison, IL 62060-1155, from October 28 to November 1, 2024. This warning letter summarizes sign",0,[3,4,6,13,14,18],"3017219182","",""],["2025-04-09","Noah Medical Corporation",2,2,"","Jian Zhang","noah-medical-corporation-702414-04092025","During an inspection of your firm located at 2075 Zanker Road, San Jose, CA 95131 on October 28, 2024, through November 26, 2024, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures bronchoscopes and a",0,[2,9,10,11,12,15,17,18,20],"3021325287","",""],["2025-04-08","Tailstorm Health Inc. dba Medivant Health",0,0,"","Viraj Gandhi","tailstorm-health-inc-dba-medivant-health-703497-04082025","You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. \u00a7 353b] 1 on October 23, 2019, and most recently on December 18, 2024. Fro",0,[1,2,11,16,17,18,21],"3022483154","",""],["2025-04-07","PMS4PMS, LLC",0,6,"","Ms. Lina M. Kennedy","pms4pms-llc-700180-04072025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, PMS4PMS, LLC, FEI 3016774658, at 4255 Research Pkwy, Clarence, from November 4 to 8, 2024. This warning letter summarizes significant violations of Current Good Ma",0,[6,13,14,16,17,18],"3016774658","",""],["2025-04-04","ICU Medical",2,2,"","Vivek Jain","icu-medical-702535-04042025","During an inspection of Smiths Medical ASD (acquired by your firm ICU Medical in January 2022) FEI: 3012307300 located at 6000 Nathan Lane N., Minneapolis, Minnesota on July 23, 2024, through August 9, 2024, investigators from the United States Food and Drug A",0,[11,17,18,20],"3012307300","",""],["2025-04-04","Wuxi Medical Instrument Factory Co., Ltd.",0,0,"","Mr. Chongjiu Li","wuxi-medical-instrument-factory-co-ltd-701044-04042025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Wuxi Medical Instrument Factory Co., Ltd., FEI 3006851654, located at No. 43 Xixin Road, Zhangjing, Xibei Town, Wuxi, from November 11 to 15, 2024. Because your dr",1,[1,2,3,6,8,13,14,18],"3006851654","",""],["2025-04-02","Empower Clinic Services, LLC dba Empower Pharma",0,0,"","Arta Shaun Noorian","empower-clinic-services-llc-dba-empower-pharma-700962-04022025","You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. \u00a7 353b] 1 on July 16, 2016, and most recently on December 6, 2024. From Au",0,[1,2,3,8,11,16,17,18,21],"3011887629","",""],["2025-04-02","Empower Clinic Services, LLC dba Empower Pharmacy",0,0,"","Jules D\u2019Souza","empower-clinic-services-llc-dba-empower-pharmacy-700964-04022025","From September 24, 2024, to October 4, 2024, U.S. Food and Drug Administration (FDA) investigators inspected your facility, Empower Clinic Services, LLC dba Empower Pharmacy, located at 7601 N Sam Houston Pkwy W Ste 100, Houston, TX 77064. During the inspectio",0,[1,2,8,18,21],"3021758709","",""],["2025-04-02","Taizhou Jingshang Cosmetics Technology Co., Ltd.",0,0,"","Mr. Zheng Liang","taizhou-jingshang-cosmetics-technology-co-ltd-701945-04022025","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Taizhou Jingshang Cosmetics Technology Co., Ltd., FEI 3014244255, located at Luqiao District, Shanhoupan Village, Hengjie Town, Taizhou, Zhejiang Province, China, from Nove",1,[6,13,14,17,18],"3014244255","",""],["2025-04-01","NWL Netherlands Services B.V.",0,0,"","Mr. Jimmy Duivenvoorden","nwl-netherlands-services-bv-701206-04012025","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, NWL Netherlands Services B.V., FEI 3003696942, at Amperestraat 12, Hillegom, Zuid-Holland, Netherlands, from October 14 to 18, 2024. This warning letter summarizes signific",1,[0,7,13,18],"3003696942","",""],["2025-03-31","DRG Instruments GmbH",2,2,"","J\u00f6rg Schl\u00f6\u03b2er","drg-instruments-gmbh-700918-03312025","During an inspection of your firm located in Marburg, Germany on November 4 through 7, 2024, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures in vitro diagnostic devices including the Salivary Cor",1,[7,9,10,11,17,18,20],"3002800697","",""],["2025-03-28","Prodose, Inc. formerly known as Spirit Pharmaceuticals LLC",0,0,"","Kunjal Joshi","prodose-inc-formerly-known-spirit-pharmaceuticals-llc-654751-03282025","This letter concerns your firm\u2019s drug listing information provided to FDA\u2019s electronic Drug Registration and Listing System (eDRLS) for your drug product, Maximum Strength Nighttime Sever Cold and Flu, NDC 68210-4210. 1 FDA has previously communicated to Spiri",0,[17],"3011773798","",""],["2025-03-27","www.thesafepills.org",0,0,"","","wwwthesafepillsorg-702942-03272025","",0,[16,17,21],"","",""],["2025-03-27","Yiling Pharmaceutical Ltd.",0,0,"","Mr. Hongzhi Li","yiling-pharmaceutical-ltd-699738-03272025","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Yiling Pharmaceutical Ltd., FEI 3011640199, located at No. 36 Zhujiang Street, Shijiazhuang, Hebei, China, from October 7 to 11, 2024. This warning letter summarizes signif",1,[3,7,14,18],"3011640199","",""],["2025-03-26","Naturista Store LLC",0,0,"","Andy Garcia","naturista-store-llc-701480-03262025","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://naturistastore.com/ from Dec 2024 to February 2025, and has observed that your website offered the product \u201cADVANCE KIN",0,[16,17,21],"3032529332","",""],["2025-03-25","Americo F. Padilla, M.D.",0,0,"","","americo-f-padilla-md-700447-03252025","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between February 1 and February 16, 2024. Investigator Richard A. Lyght, representing FDA, review",0,[9],"3005285276","",""],["2025-03-25","Amy Lightner, MD",1,4,"","","amy-lightner-md-682593-03252025","This Warning Letter informs you of objectionable conditions observed during a Food and Drug Administration (FDA) inspection conducted at your clinical study site between April 3, 2023, and April 26, 2023. The FDA Investigators met with you during the inspectio",0,[],"3026147808","",""],["2025-03-25","BioAsia Worldwide Sdn Bhd",0,0,"","Mr. Kee Pee Ho","bioasia-worldwide-sdn-bhd-700093-03252025","The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, BioAsia Worldwide Sdn Bhd, FEI 3015509166, located at U-11, Lumut Port Industrial Park, Mukim Lumut, Sitiawan, Perak from October 14 to 17, 2024. This warning lett",1,[3,4,5,6,13,14,17,18],"3015509166","",""],["2025-03-25","Thermavis",2,2,"","Mark Norman Nightingale","thermavis-613564-03252025","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter CMS# 613564, dated March 4, 2021. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Wa",0,[],"3018071929","",""],["2025-03-25","Thermoteknix Systems Ltd",2,2,"","Richard Sydney Salisbury Geraldine Anne Salisbury","thermoteknix-systems-ltd-613565-03252025","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter CMS# 613565, dated March 4, 2021. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Wa",0,[],"3009028295","",""],["2025-03-25","Westminster International Ltd",2,2,"","Peter Fowler","westminster-international-ltd-613566-03252025","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter CMS# 613566, dated March 4, 2021. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Wa",0,[],"3016736153","",""],["2025-03-24","Huangshi Hygienic Material Medicine Co., Ltd.",0,0,"","Mr. Ye Lin Chairman","huangshi-hygienic-material-medicine-co-ltd-700658-03242025","",0,[6,18],"3005543486","",""],["2025-03-24","United Health Products, Inc.",2,10,"","Brian Thom","united-health-products-inc-697777-03242025","This Warning Letter is to inform you of objectionable conditions observed during the Food and Drug Administration (FDA) inspection conducted at United Health Products, Inc. from September 23, 2024, to October 4, 2024, by an investigator from the FDA\u2019s Office o",1,[11,20],"","",""],["2025-03-21","EpiCare Acquisitions, LLC",2,2,"","Robert E. Logue","epicare-acquisitions-llc-702493-03212025","During an inspection of your firm located in Lawrenceville, NJ, US, on November 12, 2024, through December 13, 2024, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the EpiCare-Zenith\u2122 Family of",0,[9,10,11,12,18],"3015730775","",""],["2025-03-20","BPI Labs, LLC",0,0,"","Chandra Kasireddy","bpi-labs-llc-699533-03202025","This letter concerns your firm\u2019s, BPI Labs, LLC\u2019s (BPI\u2019s), distribution of its Epinephrine Chloride Nasal Solution 1 mg/mL, 10 mL. The U.S. Food and Drug Administration (FDA) reviewed your product, including product labeling. Your Epinephrine Chloride Nasal So",0,[16,17],"3015156709","",""],["2025-03-14","Advanced Pharmaceutical Technology",0,0,"","Mr. Frank M. Bardani","advanced-pharmaceutical-technology-692576-03142025","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Advanced Pharmaceutical Technology Inc., FEI 3009963974, at 132 South Central Avenue, Elmsford, from July 10 to August 1, 2024. The products you manufacture at this facilit",0,[2,4,5,6,8,14,15,16,18,20,21],"3009963974","",""],["2025-03-12","CoLabs Intl. Corp",0,6,"","Laura E. Cohen, M.D.","colabs-intl-corp-688285-03122025","This letter is to advise you that in May 2024, the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including on your website at the internet address https://www.klenskin.com/ where your \u201cKL\u0112NSKIN WASH ON SUNSCREEN\u201d drug product is avail",0,[17],"3014445455","",""],["2025-03-12","Kabana Skin Care",0,6,"","Eric Kreider, M.S.","kabana-skin-care-688254-03122025","This letter is to advise you that in June 2024, the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including at the internet address https://kabanaskincare.com/ where your \u201cKabana Body Wash +UV\u201d product is available for purchase in the",0,[16,17],"3015118914","",""],["2025-03-12","Neva Global Grup Sanayi Ic Ve Dis Ticaret Anonim Sirketi",0,0,"","Mr. Ahmet Koyuncu","neva-global-grup-sanayi-ic-ve-dis-ticaret-anonim-sirketi-699000-03122025","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Neva Global Grup Sanayi Ic Ve Dis Ticaret Anonim Sirketi, FEI 3018589922, at 14/1 Akcaburgaz Mahallesi, 137. Sokak, Esenyurt, Istanbul, from September 16 to 20, 2024. This",0,[4,6,13,14,17,18],"3018589922","",""],["2025-03-12","Rex Implants Inc.",2,2,"","Giuseppe Vercellotti","rex-implants-inc-676429-03122025","During an inspection of your firm located in Columbus, OH on December 5, 2023, through December 14, 2023, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer of the following devices: the REX Ma",0,[17,18,19,20],"3014174860","",""],["2025-03-12","Waxhead Sun Defense Company",0,6,"","Kari Kenner, CEO","waxhead-sun-defense-company-688286-03122025","This letter is to advise you that in May 2024, the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including on your website at the internet address https://gowaxhead.com/ where your \u201cWaxhead SUN DEFENSE SHAMPOO + CONDITIONER + BODY WAS",0,[17],"3021774223","",""],["2025-03-12","Yangzhou Sion Commodity Co., Ltd.",0,0,"","Mr. Chenguang Xu","yangzhou-sion-commodity-co-ltd-699183-03122025","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Yangzhou Sion Commodity Co., Ltd., FEI 3011346498, at No. 168 Longwang Road, Hangji Industrial Park, Yangzhou, Jiangsu, from September 23 to 27, 2024. This warning letter s",0,[0,6,13,14,17,18],"3011346498","",""],["2025-03-10","International Laboratories Corp",0,0,"","Mr. Robert C. Munday","international-laboratories-corp-698522-03102025","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, International Laboratories Corp, FEI 3006403166, at Bangplee District, 62 Moo 8, Bang Na-Trat Rd, Bang Phli, Samut Prakan 10540, Thailand, from September 16 to 20, 2024. Th",0,[0,6,14,18],"3006403166","",""],["2025-03-10","MG Infusions",1,4,"","Michael Garcia","mg-infusions-696890-03102025","This is to advise you that the United States Food and Drug Administration (FDA) has reviewed your website at mginfusions.com (last visited March 2025), as well as other information available to the Agency. Your website indicates that you sell fecal microbiota",0,[16,19],"3033264330","",""],["2025-03-06","Pico IV Inc.",0,0,"","Joseph Young","pico-iv-inc-700591-03062025","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address www.picoiv.com in January 2024 and has observed that your website offers \u201cPico IV,\u201d an intravenous form of cannabidiol (CBD). W",0,[16],"3034879978","",""],["2025-03-05","Annovex Pharma, Inc.",0,0,"","Adedayo Akinbi","annovex-pharma-inc-698115-03052025","You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. \u00a7 353b] 1 on October 14, 2021, and most recently on November 22, 2024. Fro",0,[1,2,11,15,16,17,18,21],"3020928491","",""],["2025-03-05","Aspen Biopharma Labs Private Limited",0,0,"","Mr. K. Sateesh Reddy","aspen-biopharma-labs-private-limited-698665-03052025","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, at Aspen Biopharma Labs Private Limited, FEI 3012796281, at Plot 10, Phase \u2013 II; Lalgadi Malakpet Village, Rangareddy, Hyderabad, Telangana, 500078, India, from September 1",0,[0,3,4,5,6,9,18],"3012796281","",""],["2025-03-05","Macsen Drugs",0,0,"","Mr. Achal Agrawal","macsen-drugs-698202-03052025","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Macsen Drugs, FEI 3015794560, at F-261, 262, 263 Riico Industrial Area Gudli, Tehsil Mavli, Udaipur, Rajasthan, India, from September 2 to 6, 2024. This warning letter summ",1,[6,14,18],"3015794560","",""],["2025-03-05","Mehran Michael Bahrami, M.D.",0,0,"","","mehran-michael-bahrami-md-703689-03052025","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between April 8 and April 19, 2024. Investigators Chantae D. Mitchell and Ana P. Barido, represen",0,[],"3030396555","",""],["2025-03-04","C & A Naturistics",0,3,"","Anakaren Lopez","c-naturistics-693439-03042025","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.productosnaturalesca.com from May 2024 to February 2025, and has observed that during this time your website offere",0,[16,17,21],"3017845321","",""],["2025-03-04","Dexcom, Inc.",2,2,"","Kevin R. Sayer","dexcom-inc-700835-03042025","During inspections of your firms located in San Diego, CA on October 21, 2024, through November 7, 2024, and Mesa, AZ on June 10, 2024, through June 14, 2024, investigators from the United States Food and Drug Administration (FDA) determined that your firm man",0,[5,9,12,17,18,20],"3004753838","",""],["2025-03-04","ProRx, LLC",0,0,"","Mr. Mark L\u2019Hommedieu","prorx-llc-696742-03042025","You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. \u00a7 353b] 2 on April 27, 2022, and most recently on November 22, 2024. From",1,[1,2,8,9,11,14,15,16,17,18,21],"3022250654","",""],["2025-03-03","Amazon.com, Inc.",0,0,"","Andy Jassy","amazoncom-inc-695821-03032025","This letter concerns your firm\u2019s distribution of products that violate the Federal Food, Drug, and Cosmetic Act (the \u201cFD&C Act\u201d). The United States Food and Drug Administration (FDA) reviewed injectable lipolytic drug products that were purchased on your websi",0,[16],"3016994737","",""],["2025-03-03","Filler Lux dba Filler Lux USA",0,0,"","Boris Kalashnikov","filler-lux-dba-filler-lux-usa-699221-03032025","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address https://fillerx.com in December 2024 and has observed that your website offers various injectable lipolytic products such as \u201cL",0,[16],"3031677657","",""],["2025-03-03","Fox Pharma LLC",0,0,"","","fox-pharma-llc-699225-03032025","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address https://foxpharma.us in January 2025 and has observed that your website offers various injectable lipolytic products, such as \u201c",0,[16],"3033935535","",""],["2025-03-03","Hyaluron Pen Store, LLC dba Glow Nest Beauty",0,0,"","Shabdan Akylbekov","hyaluron-pen-store-llc-dba-glow-nest-beauty-700256-03032025","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your websites at the internet addresses https://www.glownestbeauty.com/ and https://www.hyaworld.store/ in January 2025 and has observed that your websites offers v",0,[16],"3030230743","",""],["2025-03-03","Julian Naya Beauty LLC",0,0,"","Julie Ellis","julian-naya-beauty-llc-699782-03032025","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address https://juliannayabeauty.com/ in January 2025 and has observed that your website offers various injectable lipolytic products s",0,[16],"3034408379","",""],["2025-03-03","Natuzen Co., Ltd.",0,0,"","Mr. Young-Gi Son","natuzen-co-ltd-677942-03032025","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-24-36 dated May 3, 2024. Based on our evaluation, it appears that you have addressed the violations contained in this War",0,[],"3006731547","",""],["2025-03-03","Vivid-Scientific LLC",0,0,"","Lisa L. Currin","vivid-scientific-llc-699226-03032025","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address https://www.vividscientific.com/ in January 2025 and has observed that your website offers various injectable lipolytic product",0,[16],"3033935567","",""],["2025-02-28","Shree Jaya Laboratories PVT. LTD.",0,0,"","Mr. V. Vishnu Murthy Raju","shree-jaya-laboratories-pvt-ltd-698690-02282025","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Shree Jaya Laboratories PVT. LTD., FEI 3011845012, at Sy. No. 299, Malkapur Village and Post, Choutuppal Mandal, Yadadri Bhuvanagiri District, Telangana from September 4 to",0,[0,3,7,14,15,18],"3011845012","",""],["2025-02-28","Zhejiang Tianyu Pharmaceutical Co Ltd",0,0,"","Mr. Tu Yongjun","zhejiang-tianyu-pharmaceutical-co-ltd-631054-02282025","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-22-23 dated August 17, 2022. Based on our evaluation, it appears that you have addressed the deviations contained in this",0,[],"3010972581","",""],["2025-02-26","Granules India Limited",0,0,"","Dr. Krishna Prasad Chigurupati","granules-india-limited-697115-02262025","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Granules India Limited, FEI 3004097901, located at Survey No 160/A, 161/E, 162 and 174/A, Gagillapur Village, Dundigal-Gandimaisamma Mandal, Medchal-Malkhajgiri District, T",1,[0,3,14,18],"3004097901","",""],["2025-02-26","USApeptide.com",0,0,"","","usapeptidecom-696885-02262025","",0,[16,17,21],"","",""],["2025-02-25","Linghai ZhanWang Biotechnology Co., Ltd",0,0,"","Changhui Qi","linghai-zhanwang-biotechnology-co-ltd-697983-02252025","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our February 26, 2024 request, and subsequent corresponde",0,[6,14,18],"3015248821","",""],["2025-02-25","TKTX Numb Store",0,6,"","","tktx-numb-store-697051-02252025","This letter concerns your firm\u2019s distribution of the drug products \u201cTKTX TOPICAL ANESTHETIC CREAM 5% Lidocaine [TKTX Tub],\u201d \u201cTKTX plus 200% More Volume,\u201d and \u201cTKTX RAPID NUMB & LONG LASTING\u201d indicated for use as external analgesics prior to sensitive cosmetic",1,[16,17],"3032764599","",""],["2025-02-25","TKTX Numbing Cream USA",0,6,"","","tktx-numbing-cream-usa-702106-02252025","This letter concerns your firm\u2019s distribution of the drug products, \u201cYellow TKTX Numbing Cream 40%,\u201d \u201cWhite TKTX Numbing Cream 40%,\u201d \u201cGold TKTX Numbing Cream 40%,\u201d and \u201cBlack TKTX Numbing Cream 40%\u201d (hereinafter collectively referred to as \u201cTKTX Numbing Creams",1,[16,17],"3032764607","",""],["2025-02-25","TKTX Store",0,6,"","Kelly Chan","tktx-store-698371-02252025","This letter concerns your firm\u2019s distribution of \u201cMithra+ 10% Lidocaine,\u201d \u201cJ-PRO Cream\u201d and all your TKTX branded numbing products, 1 for use as external analgesics, among other things, 2 prior to sensitive cosmetic procedures. The United States Food and Drug",1,[16,17],"3032764602","",""],["2025-02-25","TKTX USA",0,6,"","","tktx-usa-698435-02252025","This letter concerns your firm\u2019s distribution of the drug products \u201cTKTX Blue Numbing Cream 40%,\u201d \u201cTKTX Green Numbing Cream 40%,\u201d \u201cTKTX Black Numbing Cream 40%,\u201d \u201cTKTX Gold Numbing Cream 40%,\u201d and \u201cTKTX Yellow Numbing Cream 40%\u201d (hereinafter collectively refer",1,[16,17],"3032764588","",""],["2025-02-24","Aspen Pharmacare Holdings Limited",0,0,"","Mr. Stephen Saad","aspen-pharmacare-holdings-limited-701671-02242025","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Aspen SA Sterile Operations (Pty) Ltd. (an Aspen Pharmacare Holdings Limited subsidiary), FEI 3007490529, at 8B Gibaud Road, Kortsen, Gqeberha, South Africa 6020, from Sept",0,[0,1,2,8,14,18],"3007490529","",""],["2025-02-21","Next Science LLC",2,2,"","Jon E. Swanson","next-science-llc-698114-02212025","During an inspection of your firm located in Jacksonville, Florida on August 12 through September 5, 2024, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures wound gels under the brand names SURGX\u00ae",0,[9,10,12,17,18,20],"3012271775","",""],["2025-02-21","Red Oak Instruments, LLC",2,2,"","Mr. William C. Paske, PhD","red-oak-instruments-llc-692368-02212025","During an inspection of your firm, Red Oak Instruments, LLC (Red Oak, ROI, or \u201cthe firm\u201d), located in Missouri City, Texas, on July 15, 2024, through July 26, 2024, an investigator from the United States Food and Drug Administration (FDA) determined that your",0,[11,12,17,18,20],"3003786816","",""],["2025-02-14","Sperm Bank, Inc. dba Fertility Center of California",1,4,"2026-02-19","Martin D. Bastuba, M.D.","sperm-bank-inc-dba-fertility-center-california-694273-02142025","During an inspection of your firm, Sperm Bank, Inc. dba Fertility Center of California located at 6699 Alvarado Road, San Diego, CA, conducted between June 7, 2024 and June 12, 2024, the United States Food and Drug Administration (FDA) documented significant d",1,[],"3005211905","",""],["2025-02-13","Outset Medical, Inc.",2,2,"","Leslie Trigg","outset-medical-inc-656485-02132025","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter CMS 656485, dated 7/5/2023. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning",0,[],"3010355846","",""],["2025-02-13","Zenzi Pharmaceutical Industries Pvt. Ltd.",0,0,"","Mr. Jacob Sporon-Fiedler","zenzi-pharmaceutical-industries-pvt-ltd-701130-02132025","Your facility is registered with the United States Food and Drug Administration (FDA or Agency) as a manufacturer of prescription drug products. A review of records showed that you are a contract manufacturing facility of prescription drug product that was del",1,[15,17,18],"3032916295","",""],["2025-02-11","Chem-Tech, Ltd.",0,0,"","Mr. Jason Archer","chem-tech-ltd-696920-02112025","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Chem-Tech, Ltd., FEI 1927341, at 1006 Business Highway 5, Pleasantville, IA, from September 17 to 20, 2024. This warning letter summarizes significant violations of Current",1,[4,7,9,14,18],"1927341","",""],["2025-02-10","ABR Laboratory LLC",0,0,"","Mr. Jorge D. Abraldes","abr-laboratory-llc-696872-02102025","The U.S. Food and Drug Administration (FDA) inspected your contract testing laboratory, ABR Laboratory LLC., FEI 3020570829, located at 450 North Park Road, Suite 303, Hollywood, FL 33021-6917, from September 9 to 13, 2024. This warning letter summarizes signi",1,[7,14,18],"3020570829","",""],["2025-02-10","Exer Labs, Inc.",2,2,"","Zaw L. Thet","exer-labs-inc-699218-02102025","During an inspection of your firm located in Denver, CO on October 17, 2024, through October 24, 2024, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Exer Scan. Under section 201(h) of the F",0,[9,12,13,17,18,20],"3020929899","",""],["2025-02-10","Marshalls Traditional Healthcare CC",0,0,"","Mr. Vick Maharaj","marshalls-traditional-healthcare-cc-697697-02102025","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Marshalls Traditional Healthcare CC, FEI 3014740544, at 560 Main Reef Road, Germiston, from September 19 to 23, 2024. This warning letter summarizes significant violations",1,[4,15,17,18],"3014740544","",""],["2025-02-06","Tyche Industries Ltd",0,0,"","Mr. Sandeep Gokaraju","tyche-industries-ltd-693081-02062025","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Tyche Industries Ltd, FEI 3004790309, at 6-223, Sarpavaram (V), Kakinada, from August 12 to 16, 2024. This warning letter summarizes significant deviations from Current Goo",1,[0,3,14,18],"3004790309","",""],["2025-02-05","Chengdu Innovation Pharmaceutical Co., Ltd.",0,0,"","Ren Zhongju","chengdu-innovation-pharmaceutical-co-ltd-698786-02052025","Your facility was registered with the United States Food and Drug Administration (FDA) as a manufacturer of active pharmaceutical ingredients (APIs). FDA has reviewed the records you submitted in response to our April 29, 2024 request for records and other inf",1,[14,18],"3027222600","",""],["2025-02-05","Jagsonpal Pharmaceuticals Limited",0,0,"","Mr. Manish Gupta","jagsonpal-pharmaceuticals-limited-693134-02052025","The U.S. Food and Drug Administration (FDA) inspected your registered facility, Jagsonpal Pharmaceuticals Limited, FEI 3004153045, located at B-1124, RIICO Industrial Area, Phase-III, Bhiwadi Dist., Alwar, Rajasthan, on March 20, March 27, and April 3, 2024. T",1,[4,14,17,18],"3004153045","",""],["2025-02-05","Q\u2019Apel Medical, Inc.",2,2,"","Jodie C. Fam","qapel-medical-inc-699244-02052025","During an inspection of your firm located in Fremont, CA on July 29, 2024, through August 8, 2024, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the 072 Aspiration System (also marketed under the",0,[10,11,12,17,18,20],"3015614180","",""],["2025-02-04","ISOThrive, Inc.",0,0,"","Jack Oswald","isothrive-inc-688547-02042025","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted between June 26 and June 30, 2023. Investigator Rebecca T. Davis, representing FDA, reviewed the role of ISOThrive, Inc",1,[],"3011513461","",""],["2025-02-04","Namita A. Goyal, M.D.",1,4,"","Namita A. Goyal, MD","namita-goyal-md-677324-02042025","The Food and Drug Administration (FDA) has completed an evaluation of your corrective actions in response to our Warning Letter CBER-24-677324 dated October 10, 2024. Based on our evaluation, it appears that you have addressed the violations contained in this",0,[],"3018752619","",""],["2025-02-04","Wuhu Nuowei Chemistry Co., Ltd.",0,0,"","Ms. Hongwei Xu","wuhu-nuowei-chemistry-co-ltd-697727-02042025","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Wuhu Nuowei Chemistry Co., Ltd., FEI 3014438694, at Xuancheng 323 Provincial Road, Pang, Jingde, Xuancheng, from September 2 to 6, 2024. This warning letter summarizes sign",1,[3,5,6,14,18],"3014438694","",""],["2025-01-30","Strukmyer LLC dba Strukmyer Medical",0,0,"","Mr. Sudheer Kancherla","strukmyer-llc-dba-strukmyer-medical-692686-01302025","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Strukmyer LLC dba Strukmyer Medical, FEI 3000205837, at 1801 Big Town Blvd. Ste. 100, Mesquite, TX, from July 8 to August 1, 2024. This warning letter summarizes significan",1,[2,3,5,7,13,14,18],"3000205837","",""],["2025-01-29","AmWiner & Raphe Holdings, LLC dba rapheGenerics Corp",0,0,"","Ms. Ijyahu Raphe Eze","amwiner-raphe-holdings-llc-dba-raphegenerics-corp-698782-01292025","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, AmWiner & Raphe Holdings LLC, FEI 3009569638, at 11601 Plano Road Suite 104, Dallas, Texas 75243, from June 20 to August 7, 2024. This warning letter summarizes significant",0,[4,5,13,14,16,18],"3009569638","",""],["2025-01-28","Massachusetts Institute of Technology MIT",1,4,"","Dr. Leigh M. Firn MD","massachusetts-institute-technology-mit-663218-01282025","The Food and Drug Administration (FDA) has completed an evaluation of your corrective actions in response to our Warning Letter CBER-24-663218 dated June 21, 2024. Based on our evaluation, it appears that you have addressed the violations contained in this War",0,[],"1282959","",""],["2025-01-28","Rite-Kem Incorporated",0,0,"","Mr. Mark Lovil","rite-kem-incorporated-697272-01282025","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Rite-Kem Incorporated, FEI 1000337046, at 703 Westmoreland Dr, Tupelo, Mississippi, from September 9 to 12, 2024. This warning letter summarizes significant violations of C",0,[3,4,6,10,13,14,15,18],"1000337046","",""],["2025-01-28","Shantou Kangjie Daily Chemical Industry Co., Ltd",0,0,"","Fang Yongliang","shantou-kangjie-daily-chemical-industry-co-ltd-698223-01282025","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our March 25, 2024, request for records and other informa",1,[13,14,18],"3016825286","",""],["2025-01-27","Imperial Palace Commodity -Dongguan- Co., Ltd.",0,0,"","Mr. Alan Xu","imperial-palace-commodity-dongguan-co-ltd-692842-01272025","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our March 4, 2024 request, and subsequent requests, for r",1,[4,6,13,14,18],"3014838570","",""],["2025-01-23","Center for Instrumental Analysis of China Pharmaceutical University",0,0,"","Mr. Wenbin Shen","center-instrumental-analysis-china-pharmaceutical-university-696906-01232025","The U.S. Food and Drug Administration (FDA) inspected your contract testing laboratory, Center for Instrumental Analysis of China Pharmaceutical University, FEI 3005037448, at Zhongyang Road, No. 24 Tongjiaxing Road, Nanjing, Jiangsu, from September 18 to 20,",1,[0,5,7,14,18],"3009350497","",""],["2025-01-22","Nubratori, Inc. dba Nubratori Rx",0,0,"","Robert P. Nickell","nubratori-inc-dba-nubratori-rx-700513-01222025","",0,[1,14,15,17,18,21],"3010166491","",""],["2025-01-21","Kardesler Ucan Yaglar Sanayi Anonim Sirketi",0,0,"","Ms. Sezin Zavaro","kardesler-ucan-yaglar-sanayi-anonim-sirketi-695413-01212025","Your facility was recently registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our March 15, 2024 request, and subsequent requ",1,[13,14,18],"3012634391","",""],["2025-01-17","BioStem Life Sciences",1,4,"","Jason V. Matuszewski","biostem-life-sciences-673788-01172025","The United States Food and Drug Administration (FDA) inspected your facility, located at the above address, between September 11, 2023, and September 15, 2023. During the inspection, FDA documented that your company manufactures cellular products derived from",1,[1,2,4,8,15,18],"3013239405","",""],["2025-01-17","Chara Biologics, Inc.",1,4,"","Joy Kong, M.D.","chara-biologics-inc-698004-01172025","The United States Food and Drug Administration (FDA) inspected your facility, Chara Biologics, Inc., located at the above address, between July 23, 2024, and August 16, 2024. During the inspection, FDA documented that Chara Biologics, Inc. (\u201cyou\u201d) manufactures",1,[14,16,17,18,19],"3015265204","",""],["2025-01-16","Global Calcium Pvt. Limited",0,0,"","Mr. Arif Vazirally","global-calcium-pvt-limited-692000-01162025","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Global Calcium Pvt. Limited, FEI 3004094136, at Bangalore - Hosur Highway, 125/126, Sipcot Industrial Complex, Hosur, Tamil Nadu, India 635126, from July 29 to August 2, 20",0,[0,3,6,7,14,15,18],"3004094136","",""],["2025-01-16","Mihon Corp. d/b/a VitalityVita and Boulla, LLC",0,0,"","Michael Lee","mihon-corp-dba-vitalityvita-and-boulla-llc-698165-01162025","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://vitalityvita.com from August to December 2024 and your product listings on your Amazon storefronts at https://www.amazo",1,[16,17,21],"3032246954","",""],["2025-01-15","Bioiberica, SAU",0,0,"","Mr. Luis Solera Blasco","bioiberica-sau-629115-01152025","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-22-20 dated June 30, 2022. Based on our evaluation, it appears that you have addressed the deviations contained in this W",0,[],"1000418405","",""],["2025-01-15","Sanofi",0,0,"","Mr. Paul Hudson","sanofi-690604-01152025","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Genzyme Corporation (a Sanofi subsidiary), FEI 1220423, at 8, 31, 45, 49, 51, 55, 68, 74, 76, 80 New York Ave., Framingham, MA, from June 12 to July 9, 2024. This warning l",1,[1,4,7,14,15,18],"1220423","",""],["2025-01-13","www.weightcrunchshop.com",0,0,"","","wwwweightcrunchshopcom-695815-01132025","",1,[16,17,21],"","",""],["2025-01-08","Atlanta Supersource, Inc.",0,0,"","Mr. David M. Rose","atlanta-supersource-inc-693399-01082025","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Atlanta Supersource, Inc., FEI 3016837288, located at 3655 Kennesaw 75 Parkway NW, Suite 100, Kennesaw from July 15 to 19, 2024. This warning letter summarizes significant",1,[3,17,18],"3016837288","",""],["2024-12-30","Evolutionary Biologics Inc.",1,4,"","Jim Morrison","evolutionary-biologics-inc-681586-12302024","The United States Food and Drug Administration (FDA) has reviewed your company\u2019s website at the internet address www.evolutionarybiologics.com/rx (last visited November 2024), as well as other information available to the Agency. FDA has determined that you se",1,[16],"3030708917","",""],["2024-12-19","Fagron Compounding Services, LLC dba Fagron Sterile Service",0,0,"","Jason McGuire","fagron-compounding-services-llc-dba-fagron-sterile-service-698861-12192024","You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. \u00a7 353b] 1 on October 2, 2015, and most recently on October 18, 2024. From",1,[1,2,15,16,17,18,21],"3012104093","",""],["2024-12-19","Integra LifeSciences Corporation",2,2,"","Mr. Jan De Witte","integra-lifesciences-corporation-698850-12192024","The United States Food and Drug Administration (FDA) conducted the following inspections of your firm\u2019s medical device facilities: Integra LifeSciences Corporation, located at 11 Cabot Blvd, Mansfield, MA, FEI 3014334038, from March 12, 2024 through June 5, 20",1,[2,6,9,12,18],"3014334038","",""],["2024-12-19","Viatris, Inc.",0,0,"","Mr. Scott A. Smith","viatris-inc-690897-12192024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Mylan Laboratories Limited, Inc., \u201ca Viatris company,\u201d FEI 3010453141, located at Plot No. 11, 12 & 13, Indore SEZ Pharma Zone, Phase-II, Sector-III, Pithampur, Dhar, Madhy",1,[0,6,7,9,14,18],"3010453141","",""],["2024-12-18","Bhargava Phytolab Private Limited",0,0,"","Mr. Rajeshwar Sahai Bhargava","bhargava-phytolab-private-limited-691610-12182024","",1,[1,2,4,13,17,18],"3012809762","",""],["2024-12-18","Hologic, Inc.",2,2,"","Stephen MacMillan","hologic-inc-698214-12182024","During an inspection of your firm located in Marlborough, MA on July 30, 2024, through September 24, 2024, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures class II implantable radiographic marker",1,[2,9,11,12,17,18,20],"1000120743","",""],["2024-12-18","Sombra Cosmetics, Inc.",0,0,"","Mr. Alfredo Cortazar","sombra-cosmetics-inc-692322-12182024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Sombra Cosmetics, Inc., FEI 1629960, at 5951 Office Blvd NE, Albuquerque, New Mexico, from July 15 to 26, 2024. This warning letter summarizes significant violations of Cur",1,[3,4,6,7,10,13,14,18],"1629960","",""],["2024-12-17","Akron Formulations India Private Limited",0,0,"","Mr. RamaRao Kovoor Venkata","akron-formulations-india-private-limited-693938-12172024","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our March 25, 2024 request, and subsequent correspondence",1,[2,6,14,18],"3017000602","",""],["2024-12-17","Anne\u2019s Daye Ltd dba Tampon Innovations",2,2,"","Valentina Milanova","annes-daye-ltd-dba-tampon-innovations-696362-12172024","During an inspection of your firm located in Oblast Sofia Grad, Bulgaria on July 8, 2024, through July 11, 2024, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Cannabinoid (CBD) coated tampons (",1,[10,17,18,20],"3028725772","",""],["2024-12-17","Brands International Corporation",0,0,"","Mr. David Kahan","brands-international-corporation-689983-12172024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Brands International Corporation, FEI 3007389902, at 594 Newpark Blvd, Newmarket, Ontario L3X 2S2, Canada, from June 17 to 21, 2024. This warning letter summarizes signific",1,[3,4,5,7,10,13,14,18],"3007389902","",""],["2024-12-17","Right Value Drug Stores, LLC dba Carie Boyd Pharmaceuticals",0,0,"","Evan Gilbert","right-value-drug-stores-llc-dba-carie-boyd-pharmaceuticals-694687-12172024","You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. \u00a7 353b] 1 on July 3, 2019, and most recently on December 12, 2023. From Ma",0,[1,2,4,15,16,17,18,21],"3010589333","",""],["2024-12-16","Indoco Remedies Limited",0,0,"","Ms. Aditi Kare Panandikar","indoco-remedies-limited-691594-12162024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Indoco Remedies Limited, FEI 3005124189, at L 32 33 - 34 I D C Verna Industrial Road, Vasco Da Gama, Goa, India, from July 16 to 26, 2024. This warning letter summarizes si",1,[0,1,2,10,14,18],"3005124189","",""],["2024-12-16","Skye Biologics Holdings LLC",1,4,"","Christopher M.B. Sharp","skye-biologics-holdings-llc-654466-12162024","The United States Food and Drug Administration (FDA) inspected your facility, located at 2255 Campus Dr, El Segundo, CA 90245, between November 29, 2022 and December 9, 2022. During the inspection, FDA documented that your company manufactures \u201cplacental conne",1,[1,2,8,15,16,18],"3005340932","",""],["2024-12-13","Certify Global Inc.",2,2,"","Marc Potash","certify-global-inc-613568-12132024","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter CMS# 613568, dated March 4, 2021. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Wa",0,[],"3018071931","",""],["2024-12-12","Abbott Laboratories",1,4,"","Robert B. Ford","abbott-laboratories-669353-12122024","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to Warning Letter (WL) #669353 dated 10/24/2023. Based on our evaluation, we understand you are no longer marketing Similac\u00ae Probiotic Tri-Blend; a",0,[],"1513768","",""],["2024-12-12","INCELL Corporation LLC",1,0,"","Mary Pat Moyer, PhD","incell-corporation-llc-679023-12122024","The United States Food and Drug Administration (FDA) inspected your facility located at the above address between September 25, 2023, and September 29, 2023. During the inspection, FDA documented that your company manufactures a product derived from amniotic f",1,[1,2,4,6,8,10,15,16,17,18],"3004107906","",""],["2024-12-12","XO Biologix, LLC",1,4,"","David P. Janice","xo-biologix-llc-697717-12122024","The United States Food and Drug Administration (FDA) inspected your facility located at the above address between January 3, 2024, and January 5, 2024. During the inspection, FDA documented that your company markets and distributes a product derived from amnio",1,[6,16,17,18],"3015521757","",""],["2024-12-10","Prime Vitality, Inc. dba Prime Peptides",0,0,"","Curtis Miller","prime-vitality-inc-dba-prime-peptides-695156-12102024","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address https://primepeptides.co in October 2024 and has observed that your website offers various products as \u201cpeptides\u201d including, \u201cS",0,[16],"3032711659","",""],["2024-12-10","Summit Research Peptides",0,0,"","","summit-research-peptides-695607-12102024","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://summitpeptides.shop in October 2024 and has observed that your website offers \u201cSemaglutide\u201d (or \u201cSema\u201d), \u201cRetatrutide\u201d",0,[16],"3032615861","",""],["2024-12-10","Swisschems",0,0,"","","swisschems-695663-12102024","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://swisschems.is/ in October 2024 and has observed that your website offers \u201cSemaglutide\u201d and \u201cRetatrutide\u201d products for s",0,[16],"3032908529","",""],["2024-12-10","Veronvy",0,0,"","","veronvy-694688-12102024","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.veronvy.com/ in October 2024 and has observed that your website offers \u201cElily Veronvy\u201d and \u201cElily Veronvy 40+\u201d prod",1,[16,17],"3032428843","",""],["2024-12-10","Xcel Research LLC",0,0,"","Andrew Pierce","xcel-research-llc-694608-12102024","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address https://www.xcelpeptides.com in October 2024 and has observed that your website offers various products such as \u201cRETA\u201d (Retatru",0,[16],"3032610025","",""],["2024-12-09","Phillips Precision, Inc.",2,2,"","Jeanne M. Phillips","phillips-precision-inc-697119-12092024","During an inspection of your firm located in Elmwood Park, NJ on April 22, 2024 through July 17, 2024, investigators from the United States Food and Drug Administration (FDA) determined that your firm contract manufactures orthopedic implants and instruments.",1,[3,4,18],"3003387384","",""],["2024-12-09","Xoran Technologies, LLC",2,2,"","Robert P. Bryan","xoran-technologies-llc-694229-12092024","During an inspection of your firm located in Ann Arbor, MI on June 25, 2024 through July 11, 2024, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures computed tomography (CT) systems and supporting",1,[4,10,17,18,20],"3004198450","",""],["2024-12-06","Randox Laboratories Limited",2,2,"","Steven Peter FitzGerald","randox-laboratories-limited-696569-12062024","During an inspection of your firm located in Antrim, United Kingdom on August 5, 2024 through August 8, 2024, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the RX series test systems, including",1,[3,9,10,18,20],"3014607865","",""],["2024-12-03","Applied Therapeutics, Inc.",0,0,"","Shoshana Shendelman, Ph.D.","applied-therapeutics-inc-696833-12032024","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted between April 29 and May 3, 2024. Investigators Kerun Hardeo, Benton M. Ketron, and Cheryl A. Grandinetti, representing",0,[0,9],"3017441754","",""],["2024-12-03","Han C. Phan, M.D.",0,0,"","Han C. Phan, M.D.","han-c-phan-md-696989-12032024","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between April 1 and April 5, 2024. Investigators Ann B. Borromeo and Cheryl A. Grandinetti, repre",0,[],"3014739297","",""],["2024-12-03","Micro Orgo Chem",0,0,"","Mr. Vinod Ranka","micro-orgo-chem-686458-12032024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Micro Orgo Chem, 3004513977, at 57, C-1/B, LIC sector, GIDC, VAPI, 396195, Gujarat, from April 11 to 18, 2024. This warning letter summarizes significant deviations from Cu",0,[3,4,5,6,7,14,15,18],"3004513977","",""],["2024-11-22","Argon Medical Productions & Vertrieb Gesellschaft MBH & CO",2,2,"","Mr. Richard Donaca","argon-medical-productions-vertrieb-gesellschaft-mbh-co-694763-11222024","During an inspection of your firm located in Bingen am-Rhein, Germany on 7/29/2024 through 7/31/2024, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures K3Pro and K3Pro Rapid Implant (Konus Dental I",0,[11,17,18,20],"3011575197","",""],["2024-11-22","Becton, Dickinson, and Company/CareFusion 303, Inc.",2,2,"","Mr. Thomas E. Polen","becton-dickinson-and-companycarefusion-303-inc-691601-11222024","During an inspection of your firm located in San Diego, California on May 6, 2024 through May 22, 2024, an investigator (or investigators) from the United States Food and Drug Administration (FDA) determined that your firm manufactures Pyxis Medication Managem",0,[9,10,11,12,17,18,20],"2016493","",""],["2024-11-21","Catwalk Cosmetic Laboratories Pty Ltd.",0,0,"","Mr. Greg Lavender","catwalk-cosmetic-laboratories-pty-ltd-693863-11212024","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our March 25, 2024 request for records and other informat",0,[4,6,13,14,18],"3014345294","",""],["2024-11-21","Dr. Brite, LLC",0,0,"","Dr. Pooneh Ramezani, DDS, Dr. Paris Sabo, MD","dr-brite-llc-684466-11212024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Dr. Brite, LLC, 3016665985, at 1536 Kimberly Avenue, Fullerton, California from April 2 to 5, 2024. This warning letter summarizes significant violations of Current Good Ma",0,[6,13,14,15,16,17,18],"3016665985","",""],["2024-11-21","LCC Ltd.",0,0,"","Mr. Sung-chun Baik","lcc-ltd-688576-11212024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, LCC Ltd., FEI 3007255059, at 738-13 Samyang-ro, Daeso-myeon, Eumseong-gun, Chungcheongbuk-do, from March 18 to 22, 2024. This warning letter summarizes significant violatio",0,[0,6,7,14,16,17,18],"3007255059","",""],["2024-11-20","Eurosirel S.P.A",0,0,"","Mr. Ernesto Leonelli","eurosirel-spa-690733-11202024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Eurosirel S.P.A., FEI 3015892095, at Viale Europa 30, Cusago, Milan, from May 20 to 24, 2024. This warning letter summarizes significant violations of Current Good Manufact",0,[13,14,18],"3015892095","",""],["2024-11-18","Hangzhou Huiji Biotechnology Co., Ltd.",0,0,"","Mr. Zhan Libin","hangzhou-huiji-biotechnology-co-ltd-692844-11182024","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our March 4, 2024 request for records and other informati",0,[6,13,14,15,17,18],"3010461961","",""],["2024-11-15","Centura Pharmaceuticals Inc",0,6,"","Rahul Patel","centura-pharmaceuticals-inc-684733-11152024","This letter is to advise you that in April 2024, the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including on your website at the internet addresses www.centurapharma.com and centurabltcream.com, where your \u201cBLT 1-2-3 Cream\u201d drug pr",0,[16,17],"3013017711","",""],["2024-11-13","Guangzhou Four E\u2019s Scientific Co., Ltd.",0,0,"","Mr. Nelson Wan","guangzhou-four-es-scientific-co-ltd-692061-11132024","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our March 4, 2024 request, and subsequent correspondence,",0,[2,4,14,18],"3009155756","",""],["2024-11-12","Zhejiang Uniquality Nursing Products Technology Co., Ltd. dba ZheJiang YouQuan Care Products Technology Co., Ltd.",0,0,"","Mr. Shouquan Zhou","zhejiang-uniquality-nursing-products-technology-co-ltd-dba-zhejiang-youquan-care-products-technology","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our March 11, 2024 and April 15, 2024 requests for record",0,[13,14,18],"","",""],["2024-11-07","Originitalia SRL",0,0,"","Mr. Pietro Giulio Orso","originitalia-srl-687935-11072024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Originitalia SRL, FEI 3004420738, located at Vicolo Don Antonio Menin 6, Caldogno, Vicenza, 36030, Italy, from May 20 to 24, 2024. This warning letter summarizes significan",1,[3,4,6,13,14,17,18],"3004420738","",""],["2024-11-07","Zhejiang Qimei Cosmetics Co., Ltd.",0,0,"","Mr. Jinyan Wang","zhejiang-qimei-cosmetics-co-ltd-690950-11072024","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our March 11, 2024 request, and subsequent requests, for",1,[13,14,18],"3018321301","",""],["2024-11-06","Richard W. Foltin, Ph.D.",0,0,"","","richard-w-foltin-phd-690189-11062024","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted between February 28 and March 17, 2023. Investigator Omadevi Somai, representing FDA, reviewed your role as the sponsor",0,[],"3003469576","",""],["2024-11-06","Unexo Lifesciences, Private Limited",0,0,"","Mr. Saurabh Bansal","unexo-lifesciences-private-limited-688163-11062024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Unexo Life Sciences, Private Limited, FEI 3013514280, located at B16, Sector 4, Bawana Industrial Area, New Delhi, Delhi, 110039 India, from May 1 to 14, 2024. This warning",1,[0,3,6,14,15,18],"3013514280","",""],["2024-11-05","Colgate-Palmolive/Tom's of Maine, Inc.",0,0,"","Mr. Noel Wallace","colgate-palmolivetoms-maine-inc-687043-11052024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Tom's of Maine, Inc., FEI 1218077, at 27 Community Dr., Sanford, ME, from May 7 to 22, 2024. This warning letter summarizes significant violations of Current Good Manufactu",1,[2,3,9,10,14,18],"1218077","",""],["2024-11-05","Multaler et Cie SAS",0,0,"","Mr. Alexis Wolkowinski","multaler-et-cie-sas-685009-11052024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Multaler et Cie SAS, FEI 3010165406, at 1 Rue Ambroise Croizat, Argenteuil, Val d\u2019Oise, from April 15 to 17, 2024. This warning letter summarizes significant violations of",1,[13,16,17,18],"3010165406","",""],["2024-11-01","Frontier Biologics, LLC",1,5,"","Chad W. Justice","frontier-biologics-llc-686059-11012024","The United States Food and Drug Administration (FDA) inspected your facility, located at the above address between February 27, 2024, and March 8, 2024. During the inspection, FDA documented that your company manufactures a human amniotic fluid derived product",1,[1,2,8,16,18],"3018748915","",""],["2024-11-01","Owens & Minor, Inc. dba American Contract Systems, Inc.",2,2,"","Edward A. Pesicka","owens-minor-inc-dba-american-contract-systems-inc-695683-11012024","During an inspection of your firm, American Contract Systems, (ACS) Inc., in Tiffin OH, FEI 3008492337, on August 5 through 14, 2024, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures sterile conve",1,[2,12,18,20],"3008492337","",""],["2024-10-30","Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd.",0,0,"","Mr. Xiangqi Zhang","tianjin-darentang-jingwanhong-pharmaceutical-co-ltd-683619-10302024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd., (also known as Tianjin Pharmaceutical Da Ren Tang Group Jing Wan Hong Co., Ltd.), FEI 3006283468, at No. 20 Daming S",0,[3,4,6,15,17,18],"3006283468","",""],["2024-10-29","Armstrong County Memorial Hospital",0,0,"","Nichole Geraci, MBA","armstrong-county-memorial-hospital-692080-10292024","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted between November 2, 2023, and November 8, 2023, of the Armstrong County Memorial Hospital (ACMH) Institutional Review B",1,[],"3011851548","",""],["2024-10-28","Rontis Hellas S.A.",2,2,"2026-03-12","Ms. Efi Soultou","rontis-hellas-sa-695160-10282024","",1,[2,4,11,17,18,20],"3011142981","",""],["2024-10-24","Fancy Drops Beauty LLC",0,0,"","","fancy-drops-beauty-llc-688469-10242024","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://fancydropsbeauty.com/ in July 2024 and has observed that your website offers \u201cFancy Drops Color Changing Solutions Eye",1,[16],"3031667118","",""],["2024-10-23","MedOffice Saglik Endustri Anonim Sirketi",0,0,"","Mr. Yucel Teker","medoffice-saglik-endustri-anonim-sirketi-687586-10232024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, MedOffice Saglik Endustri Anonim Sirketi, FEI 3019167311, at Ic Kapi No.1, No 9-1 Yazibasi Mahallesi, Kuscu Caddesi, Torbali, Izmir 35880, Turkey, from May 6 to 10, 2024. T",1,[3,4,13,14,18],"3019167311","",""],["2024-10-22","Wello, Inc.",2,2,"","Mr. Alan C. Heller","wello-inc-664806-10222024","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 664806, dated November 8, 2023). Based on our evaluation, it appears that you have addressed the violation(s) contained in t",0,[],"3011214569","",""],["2024-10-21","Choice All Natural, Inc. dba Om Botanical",0,0,"","Mr. Sudhir Shah","choice-all-natural-inc-dba-om-botanical-685615-10212024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Choice All Natural, Inc. dba Om Botanicals, Inc., FEI 3015097434, at 1019 Classic Road, Apex, from January 17 to February 26, 2024. This warning letter summarizes significa",1,[6,16,17,18],"3015097434","",""],["2024-10-18","Rolence Ent. Inc.",2,2,"","Chang Lin Chiu","rolence-ent-inc-695010-10182024","During an inspection of your firm located in Taoyuan, Taiwan on July 8, 2024, through July 11, 2024, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures XR-01 Portable X-ray System. Under section 201",1,[9,10,11,12,17,18,20],"","",""],["2024-10-17","Diora Kimya Sanayi ve Ticaret Limited Sirketi",0,0,"","Ms. Elif M. Diri","diora-kimya-sanayi-ve-ticaret-limited-sirketi-688271-10172024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Diora Kimya Sanayi ve Ticaret Limited Sirketi, FEI 3013927966, at Baspinar Osb 2 Bolge, Street No: 26, Mahallesi, 83226 Nolu Caddesi, Sehitkamil, Gaziantep, from May 27 to",1,[3,4,13,17,18],"3013927966","",""],["2024-10-11","Adept Medical Ltd.",2,2,"","Mr. Murray Fenton","adept-medical-ltd-692226-10112024","During an inspection of your firm located in Auckland, New Zealand on May 13, 2024, through May 16, 2024, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Tympanostomy Tubes \"NeoZoline Ventilation",0,[2,9,15,17,18,20],"","",""],["2024-10-11","Blackfly Investments, LLC dba Molecular\u00ae Testing Labs",1,4,"","Adam Blackwell","blackfly-investments-llc-dba-molecularr-testing-labs-680324-10112024","The United States Food and Drug Administration (FDA or the Agency) has learned that your firm, Blackfly Investments, LLC dba Molecular Testing Labs (MTL), is offering for sale in the United States a human immunodeficiency virus (HIV) serological diagnostic dri",1,[17,18,20],"3012598266","",""],["2024-10-10","Analytical Food Laboratories, Inc.",0,0,"","Ms. Shannon Colleen Villanueva","analytical-food-laboratories-inc-687513-10102024","The U.S. Food and Drug Administration (FDA) inspected your contract testing laboratory, Analytical Food Laboratories, Inc., FEI 3005057567, at 860 Greenview Drive, Grand Prairie, Texas, from May 7 to 17, 2024. This warning letter summarizes significant violati",1,[5,7,14,18],"3005057567","",""],["2024-10-10","Namita A. Goyal, M.D.",1,4,"","","namita-goyal-md-677324-10102024","This Warning Letter informs you of objectionable conditions observed during a Food and Drug Administration (FDA) inspection conducted at your clinical study site between June 12, 2023 and June 23, 2023. The FDA investigator met with you during the inspection t",0,[],"3018752619","",""],["2024-10-10","Soliteint Kozmetikai KFT",0,0,"","Dr. Hossam Mostafa","soliteint-kozmetikai-kft-685146-10102024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Soliteint Kozmetikai KFT, FEI 3007001714, at Moricz Zsigmond UT 37, Fot, from April 15 to 19, 2024. This warning letter summarizes significant violations of Current Good Ma",1,[4,6,13,14,15,18],"3007001714","",""],["2024-10-08","Hemarus LLC",1,4,"","Padmasree Chigurupati","hemarus-llc-688656-10082024","During an inspection of your firm, Hemarus LLC, located at 1295 NW 40th Avenue, Suite 201, Lauderhill, Florida, conducted between April 15, 2024, and April 30, 2024, the United States Food and Drug Administration (FDA) documented significant deviations from th",0,[14,18],"3019769008","",""],["2024-10-07","Hangzhou Glamcos Biotech Co., Ltd.",0,0,"","Ai Hong Ruan","hangzhou-glamcos-biotech-co-ltd-692583-10072024","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our March 4, 2024 request for records and other informati",0,[6,13,15,16,17,18,21],"3017053743","",""],["2024-10-02","Omni Lens Pvt. Ltd.",0,0,"","Mr. Ravi Srivastava","omni-lens-pvt-ltd-688151-10022024","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in responses to our November 21, 2023 and April 5, 2024, requests for re",1,[1,14,17,18],"3008449456","",""],["2024-10-01","Amnio Technology, LLC",1,4,"","Merrill B. Stromer","amnio-technology-llc-646460-10012024","During an inspection of your firm, Amnio Technology, LLC, located at 22510 N. 18th Drive, Phoenix, AZ 85027, conducted between August 15, 2022, and August 29, 2022, and your storage and distribution facility, located at (b)(4) , conducted between August 17, 20",1,[2,4,10,16,19],"3011545418","",""],["2024-10-01","Pinnacle Transplant Technologies, LLC",1,4,"","Roger W. Rose","pinnacle-transplant-technologies-llc-646783-10012024","During an inspection of your firm, Pinnacle Transplant Technologies, LLC (hereafter referred to as \u201cPinnacle\u201d), located at 1125 W. Pinnacle Peak Road, Bldg. 1, Suite 103, Phoenix, AZ 85027, conducted between August 15, 2022 and August 29, 2022, the United Stat",1,[1,2,3,8,16,19],"3008927553","",""],["2024-09-30","Mexicanrxpharm.com",0,0,"","","mexicanrxpharmcom-693163-09302024","",0,[16,17,21],"","",""],["2024-09-27","Louisiana State University Health Science Center IRB",0,0,"","Charles C. Coleman, M.D.","louisiana-state-university-health-science-center-irb-686088-09272024","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted between July 17, 2023, and July 26, 2023, of the Louisiana State University Health Science Center, New Orleans (LSUHSC)",0,[],"2310620","",""],["2024-09-26","Makra Kozmetika D.O.O.",0,0,"","Ms. Belkisa Grbic","makra-kozmetika-doo-684125-09262024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Makra Kozmetika D.O.O., FEI 3019638306, at Kolodvorska Cesta 2, 4000 Kranj from April 8 to 12, 2024. This warning letter summarizes significant violations of Current Good M",0,[3,4,11,13,14,15,18],"3019638306","",""],["2024-09-26","Supercore Products Group, Inc.",0,0,"","Christopher Ingram","supercore-products-group-inc-690510-09262024","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address, https://www.hardsteelusa.com which redirects to https://supercoreintl.com/ from May to September 2024, where you take orders f",0,[16,17,21],"3030619823","",""],["2024-09-25","Outin Futures Corp.",0,0,"","Mr. Chang Bae Moon","outin-futures-corp-684688-09252024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Outin Futures Corp., FEI 3011572099, at 150 Gieopdosil-Ro, Daesowon-Myeon Chungju, Chungcheongbuk, Korea (the Republic of) from March 25 to 29, 2024. This warning letter su",0,[0,3,4,5,6,7,14,17,18],"3011572099","",""],["2024-09-24","MMC Healthcare Ltd.",0,0,"","Mr. Nageswara Rao Gupta Manepalli","mmc-healthcare-ltd-684644-09242024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, MMC Healthcare Ltd., FEI 3014773352, at 34-B Sidco Industrial Estate, Thirumazhisai, Chennai, Tamil Nadu, from March 25 to 30, 2024. This warning letter summarizes signific",0,[0,2,4,5,6,7,14,18],"3014773352","",""],["2024-09-20","Azurity Pharmaceuticals, Inc.",0,0,"2026-03-03","Richard Blackburn","azurity-pharmaceuticals-inc-656489-09202024","The U.S. Food and Drug Administration inspected your drug manufacturing facility, Azurity Pharmaceuticals, Inc. FEI 3003395329, at 841 Woburn Street, Wilmington, MA, from February 2, 2023, to March 2, 2023. Based on our inspection and subsequent review of your",1,[4,6,7,10,14,16,18],"3003395329","",""],["2024-09-18","Media Networks Sydney Pty Limited",0,0,"","Gilad Wielunski","media-networks-sydney-pty-limited-687044-09182024","The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 2716. Based on our evaluation, it appears that you have discontinued your listings for Mylanta 2go Antacid Double Strength (NDC 8",0,[],"3027059496","",""],["2024-09-12","Nomida.biz",0,0,"","","nomidabiz-687590-09122024","",1,[16,17,21],"","",""],["2024-09-11","Quality CDMO, Inc.",0,0,"","Anin Shakiba","quality-cdmo-inc-665961-09112024","The U.S. Food and Drug Administration inspected your drug manufacturing facility, Quality CDMO, Inc. FEI 3017569510, at 5000 South Freeway, Suite 106, Fort Worth, TX, from June 12 \u2013 16, 2023. Based on our inspection and subsequent review of your firm\u2019s website",0,[16],"3017569510","",""],["2024-09-11","Zen Enterprises LLC",0,0,"","David Makima","zen-enterprises-llc-678407-09112024","The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 2644. Based on our evaluation, you have discontinued Zen Sports Balm, NDC 73048-000, Zen Hemp Balm, NDC 73048-001, Zen Hand Sanit",0,[],"3013828269","",""],["2024-09-10","Aromas Para El Alma S.A.",0,0,"","Ms. Andrea Becerra","aromas-para-el-alma-sa-672728-09102024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Aromas Para El Alma S.A., FEI 3018061317, at Oficentro Ultima Park 2, Bodega No. 74, Calle Mango, Guachipel\u00edn, San Rafael, Escazu, San Jose 10203, Costa Rica, from October",1,[4,6,13,14,15,16,17,18],"3018061317","",""],["2024-09-10","Micro-X Ltd.",2,2,"","Kingsley Hall","micro-x-ltd-692084-09102024","During an inspection of your firm located in Tonsley, South Australia on May 20, 2024, through May 23, 2024, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures Micro-X Rover Mobile X-Ray Systems. Unde",1,[9,10,11,17,18,20],"","",""],["2024-09-10","Mid-Link Testing Company, Ltd",2,2,"","Xiaoming (Diana) Hong","mid-link-testing-company-ltd-687111-09102024","This Warning Letter is to inform you of objectionable conditions observed during the United States Food and Drug Administration (FDA) inspection conducted at Mid-Link Testing Company, Ltd from February 26, 2024, to March 6, 2024, by investigators from the FDA\u2019",1,[20],"3027541118","",""],["2024-09-10","Sanitation & Environmental Technology Institute dba SDWH",2,2,"","Qiming Tian, Ph.D.","sanitation-environmental-technology-institute-dba-sdwh-687970-09102024","This Warning Letter is to inform you of objectionable conditions observed during the United States Food and Drug Administration (FDA) inspection conducted at Sanitation & Environmental Technology Institute (dba SDWH), Ltd. from March 6, 2024, to March 15, 2024",1,[20],"3008943787","",""],["2024-09-09","EnviroServe Chemicals & Cleaners Ltd.",0,0,"","Mr. H. Arthur Matossian","enviroserve-chemicals-cleaners-ltd-674090-09092024","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our June 16, 2022 request for records and other informati",1,[6,13,14,15,16,17,18],"3011214285","",""],["2024-09-04","Torrent Pharmaceuticals Limited",0,0,"","Mr. Jinesh Shah","torrent-pharmaceuticals-limited-585255-09042024","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-20-03 dated October 8, 2019. Based on our evaluation, it appears that you have addressed the violations contained in this",0,[],"3005029956","",""],["2024-09-03","Avaria Health & Beauty Corp.",0,0,"","Dr. Keith Burk","avaria-health-beauty-corp-685248-09032024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Avaria Health & Beauty Corp., FEI 3014583374, at 650 Jamieson Parkway, Unit 5, Cambridge, Ontario, from April 22 to 30, 2024. This warning letter summarizes significant vio",1,[4,13,14,18],"3014583374","",""],["2024-08-30","Root Bioscience Brands, LLC dba Naternal",0,8,"","Garrett Perdue","root-bioscience-brands-llc-dba-naternal-673646-08302024","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.naternal.com in August 2024 and has observed that your website offers various products which you represent contain, in part, cannabidiol (CBD), cannabige",1,[16,18,19],"3030093357","",""],["2024-08-30","Wissner-Bosserhoff GmbH",2,2,"","Mr. Thomas C. Erbsloeh","wissner-bosserhoff-gmbh-690242-08302024","During an inspection of your firm located in Hauptstr. 4-6, North Rhine-Westphalia, Germany on April 22, 2024, through April 25, 2024, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures nursing beds",0,[4,9,11,12,13,17,18,20],"3015979371","",""],["2024-08-29","Orean Personal Care Ltd.",0,0,"","Mr. Daniel Williams","orean-personal-care-ltd-682813-08292024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Orean Personal Care Ltd., FEI 3010999645, at Unit E1, Stubs Beck Lane, West 26 Ind. Estate, Cleckheaton, from March 11 to 15, 2024. This warning letter summarizes significa",1,[3,4,6,7,13,14,15,17,18],"3010999645","",""],["2024-08-29","Zydus Lifesciences Limited",0,0,"2025-12-16","Dr. Sharvil Patel","zydus-lifesciences-limited-685224-08292024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Zydus Lifesciences Limited, FEI 3013712903, at Survey No. 434/6/B & 434/1/K, Vadodara \u2013 Halol Highway Village - Jarod, Taluka - Waghodia, Gujarat, from April 15 to 23, 2024",1,[1,2,3,4,10,14,18],"3013712903","",""],["2024-08-27","Everymarket Inc.",0,0,"","Christopher Baton","everymarket-inc-688348-08272024","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.everymarket.com/ in July 2024 and has observed that your website offers the products \u201cVail-Bon Jie Yang Wan\u201d and \u201cO",1,[16,17,21],"3016957698","",""],["2024-08-27","MexHealth LLC d/b/a Al Natural E-Shop",0,0,"","Travis Bunch","mexhealth-llc-dba-al-natural-e-shop-682383-08272024","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://alnaturaleshop.com/ in April 2024 and July 2024 and has observed that your website offers the product \u201cOssos-Sans\u201d for",1,[16,17,21],"3030379079","",""],["2024-08-27","SoloVital",0,0,"","German Alegre","solovital-688046-08272024","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.solovital.com/ in June 2024 and has observed that your website offers the product \u201cUmary,\u201d which is also referred t",1,[16,17,21],"3030905367","",""],["2024-08-20","AnuMed International, LLC",0,0,"","Julie R. Alcantar","anumed-international-llc-674310-08202024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, AnuMed International, LLC, FEI 3010164449, at 3908 E Broadway Rd, Suite 110, Phoenix, Arizona from November 1 to 7, 2023. FDA also reviewed your website at the Internet add",0,[13,16,17,18,21],"3010164449","",""],["2024-08-20","Julio R. Flamini, M.D./Clinical Integrative Research Center of Atlanta",0,0,"","","julio-r-flamini-mdclinical-integrative-research-center-atlanta-691123-08202024","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between February 28 and March 11, 2024. Investigator Koffi Amegadje, representing FDA, reviewed y",1,[9],"3014137184","",""],["2024-08-20","Mother Stem Institute, Corp.",1,4,"","Alvaro Skupin, M.D.","mother-stem-institute-corp-680118-08202024","This is to advise you that the United States Food and Drug Administration (FDA) has reviewed your website at www.mothersteminstitute.com in August 2024 as well as your firm\u2019s response to the agency\u2019s records request under section 704(a)(4) of the Federal Food,",1,[17,19,21],"3030431122","",""],["2024-08-16","Kogniz, Inc.",2,2,"","Jed Putterman","kogniz-inc-613569-08162024","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS #613569, dated March 4, 2021). Based on our evaluation, it appears that you have addressed the violations contained in this Wa",0,[],"3018071932","",""],["2024-08-16","Regenerative Processing Plant, LLC",1,5,"","Carl R. Harrell, MD","regenerative-processing-plant-llc-672154-08162024","The United States Food and Drug Administration (FDA) conducted an inspection of your firm, Regenerative Processing Plant, LLC (hereafter \u201cRPP\u201d), FEI 3011320041, located at 34176 US Highway 19 N, Palm Harbor, FL, between June 20, 2023, and June 30, 2023. FDA in",1,[1,2,6,8,10,15,16,17,18],"3011320041","",""],["2024-08-15","Eugia Pharma Specialities Limited",0,0,"","Mr. Yugandhar Puvvala","eugia-pharma-specialities-limited-681905-08152024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Eugia Pharma Specialities Limited (Unit III), FEI 3008461619, at Plot No.: 4, 34 to 48, EPIP, TSIIC, IDA-Pashamylaram, Patancheru (Mandal), Sangareddy, Hyderabad, Telangana",0,[0,1,2,6,8,14,15,18],"3008461619","",""],["2024-08-15","Intercos Europe S.p.A",0,0,"","Mr. Gianandrea Ferrari","intercos-europe-spa-682273-08152024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Intercos Europe S.p.A, FEI 1000181428, at Via Guglielmo Marconi 84, Agrate Brianza, from March 11 to 15, 2024. This warning letter summarizes significant violations of Curr",0,[0,7,13,14,15,18],"1000181428","",""],["2024-08-15","Media Networks Sydney Pty Limited",0,0,"","Gilad Wielunski","media-networks-sydney-pty-limited-687044-08152024","This letter concerns your firm\u2019s drug listing information provided to FDA\u2019s electronic Drug Registration and Listing System (eDRLS) for the following drug products: 1 84177-0801 Mylanta 2go Antacid Double Strength 84177-0020 Microlax Enema Your firm has not fu",0,[17,21],"3027059496","",""],["2024-08-14","Tan-Alize Kozmetick ve Temizlik Urunleri Sanayi ve Ticaret A.S.",0,0,"","Mr. Hakan Tuna","tan-alize-kozmetick-ve-temizlik-urunleri-sanayi-ve-ticaret-659854-08142024","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-23-29 dated August 3, 2023. Based on our evaluation, it appears that you have addressed the violations contained in this",0,[],"3004135088","",""],["2024-08-13","Optikem International, Inc.",2,2,"","Ms. Sally Cook","optikem-international-inc-683606-08132024","During an inspection of your firm located at 2172 S. Jason St. in Denver, CO, on 2/26/24 through 3/1/24, investigators from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer of the Sereine brand ophthalmic medical",1,[1,2,4,9,12,15,17,18,20],"1720129","",""],["2024-08-08","Shenzhen Moyeah Intelligent Life Technology Co.",2,2,"","Tingjun Yan","shenzhen-moyeah-intelligent-life-technology-co-677092-08082024","The United States Food and Drug Administration (FDA) has learned that your firm is offering for sale in the United States the following products without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act): o CPAP",1,[2,17,18,20],"3030405443","",""],["2024-08-07","Adventure Innovations LLC",2,2,"","Ryan White","adventure-innovations-llc-676842-08072024","The United States Food and Drug Administration (FDA) has learned that your firm is offering for sale in the United States the Sani Bot D3 without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act). Under section",1,[17,18,20],"","",""],["2024-08-07","LEEL Tech",2,2,"","Xiong Li","leel-tech-677297-08072024","The United States Food and Drug Administration (FDA) has learned that your firm is offering for sale in the United States the CLYN (CZ001& CLYN Universal), LEEL, and SOLID (Solid CPAP & ONECLICK SOLID) without marketing clearance or approval, in violation of t",1,[17,18,20],"3030414279","",""],["2024-08-07","Natures Pillows, Inc. and Top Dog Direct, LLC",2,2,"","William McAlister","natures-pillows-inc-and-top-dog-direct-llc-676849-08072024","",1,[17,18,20],"3011278773","",""],["2024-08-01","Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd.",0,0,"","Mr. Honghui Cheng","guangzhou-baiyunshan-jingxiutang-pharmaceutical-co-ltd-675823-08012024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd., FEI 3006010954, at 249 Poyang Road, Huangqi, Dali Town, Nanhai District, Foshan City, Guangdong, China, from Decem",0,[14,18],"3006010954","",""],["2024-07-30","Barkey GmbH & Co. KG",1,4,"","Christian Barkey/Thomas Barkey","barkey-gmbh-co-kg-657073-07302024","The United States Food and Drug Administration (FDA) has reviewed your firm\u2019s corrective actions in response 1 to our Warning Letter issued to you on January 31, 2024. Based on our evaluation, it appears that you have addressed the violation(s) detailed in the",0,[],"3006629881","",""],["2024-07-26","CARsgen Therapeutics Corporation",1,4,"","Zonghai Li, M.D.","carsgen-therapeutics-corporation-686504-07262024","The United States Food and Drug Administration (FDA) inspected your facility located at the above address between November 28, 2023, and December 6, 2023. During the inspection, FDA documented significant violations of current good manufacturing practice (CGMP",0,[1,3,8,17,18],"3020703259","",""],["2024-07-25","Amazon.com, Inc.",0,0,"","Andy Jassy","amazoncom-inc-679523-07252024","This letter concerns your firm\u2019s distribution of products that violate the Federal Food, Drug, and Cosmetic Act (the \u201cFD&C Act\u201d). The United States Food and Drug Administration (FDA) reviewed chemical peel drug products that were purchased on your website, www",0,[11,16],"3016994737","",""],["2024-07-25","ISIS.GOLD",0,0,"","Michelle Golde","isisgold-679948-07252024","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.isis.gold/ in February and March 2024 and has observed that your website offers numerous chemical peel drug product",0,[11,16],"3030599243","",""],["2024-07-25","Matte Beauty",0,0,"","Terry Palmer","matte-beauty-679463-07252024","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.mattebeauty.co/ in March and April 2024 and has observed that your website offers numerous chemical peel drug produ",0,[11,16],"3030575346","",""],["2024-07-25","Repare Skincare",0,0,"","Karen Martin","repare-skincare-680247-07252024","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website, at the internet address https://repareskincare.com in March 2024 and has observed that your website offers numerous chemical peel drug products; inclu",0,[11,16],"3030604996","",""],["2024-07-25","Skin Beauty Solutions",0,0,"","Cassandra Pryor","skin-beauty-solutions-683006-07252024","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website, at the internet address https://www.skinbeautysolutions.com/ in April 2024 and has observed that your website offers numerous chemical peel drug produ",0,[11,16],"3030830526","",""],["2024-07-25","Walmart, Inc.",0,0,"","Doug McMillon","walmart-inc-683095-07252024","This letter concerns your firm\u2019s distribution of a chemical peel drug product that violates the Federal Food, Drug, and Cosmetic Act (the \u201cFD&C Act\u201d). The United States Food and Drug Administration (FDA) reviewed \u201cSkin Beauty Solutions lactic acid skin peel 90",0,[11,16],"3014706754","",""],["2024-07-23","Vitang Technology LLC",2,2,"","Ronald Jiang","vitang-technology-llc-653455-07232024","",0,[],"3015549533","",""],["2024-07-22","V10Suppliers.com",0,0,"","","v10supplierscom-685496-07222024","",0,[16,17,21],"","",""],["2024-07-18","Jiangsu Caina Medical Co., Ltd",2,2,"","Jun Lu Board","jiangsu-caina-medical-co-ltd-687033-07182024","",0,[9,10,18,20],"3005670221","",""],["2024-07-18","Jiangsu Shenli Medical Production Co., Ltd.",2,2,"","Liqun Yang","jiangsu-shenli-medical-production-co-ltd-687035-07182024","",0,[12,18,20],"3003902757","",""],["2024-07-17","Velocity Pharma LLC",0,0,"","Mr. Ankur J. Shah","velocity-pharma-llc-676434-07172024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Velocity Pharma LLC, FEI 2000044401, at 210 Sea Lane, Farmingdale, NY from November 3 to December 14, 2023, after an FDA inspection revealed violative conditions at Kilitch",0,[1,2,13,18],"2000044401","",""],["2024-07-11","Brassica Pharma Pvt. Ltd.",0,0,"","Mr. Uday Chile","brassica-pharma-pvt-ltd-679005-07112024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Brassica Pharma Pvt. Ltd., FEI 3014129013, at Plot No. T-68, T 68 (Pt), T-63, Midc, Tarapur, Boisar, Thane from January 15 to 19, 2024. This warning letter summarizes signi",0,[0,1,2,4,5,6,8,14,15,18],"3014129013","",""],["2024-07-11","Jiangsu Hengrui Pharmaceuticals Co., Ltd.",0,0,"","Mr. Hongbin Dai","jiangsu-hengrui-pharmaceuticals-co-ltd-679790-07112024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Jiangsu Hengrui Pharmaceuticals Co., Ltd., FEI 3007373503, at 38 Huanghe Road, Economic and Technological Development Zone, Lianyungang, from January 8 to 16, 2024. This wa",0,[0,1,2,3,4,6,8,9,14,15,18],"3007373503","",""],["2024-07-11","Nowrez & Ismail Shukri Company",0,0,"","Mr. Nowrez Shukri","nowrez-ismail-shukri-company-682810-07112024","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our September 12, 2022, and February 26, 2024 requests fo",0,[6,13,18],"3009721234","",""],["2024-07-09","Cholrem Pty Ltd dba Cholrem and Cholrem Pharmaceuticals",0,0,"","Kyle Hodgetts","cholrem-pty-ltd-dba-cholrem-and-cholrem-pharmaceuticals-684036-07092024","This letter is to advise you that the United States (U.S.) Food and Drug Administration (FDA) reviewed your websites at www.cavadex.com, www.cholrem.com, www.cholrem.com.au, www.cholrem-cavadex.com, www.remchol.com, and www.cavadextrin.com in May 2024. We have",0,[16],"3030694317","",""],["2024-07-08","Fischer Analysen Instrumente Gmbh",2,2,"","Dr. Martin Schaich","fischer-analysen-instrumente-gmbh-650388-07082024","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS# 650388, dated February 3, 2023). Based on our evaluation, it appears that you have addressed the violations contained in this",0,[],"3010837197","",""],["2024-07-08","YangZhou SuXiang Medical Instrument Co., Ltd.",0,0,"","Mr. Bian Xiangli","yangzhou-suxiang-medical-instrument-co-ltd-686655-07082024","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our August 15, 2022 request for records and other informa",0,[4,13,14,18],"3014321771","",""],["2024-07-02","Premier Manufacturing Products, LLC",0,0,"","James P. Morrissette","premier-manufacturing-products-llc-678912-07022024","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed labeling obtained from an inspection of your drug manufacturing facility, Atofil, LLC, from January 22 to 25, 2024, from which FDA observed that you offer numerous",0,[16],"3011015632","",""],["2024-06-28","Berkeley Biologics, LLC, previously operating as Elutia, Inc. \u2013 Orthobiologics Business Unit, formerly Aziyo Biologics, Inc.",1,4,"","Mesfin Mengesha","berkeley-biologics-llc-previously-operating-elutia-inc-orthobiologics-business-unit-formerly-aziyo","During an inspection of your firm, Berkeley Biologics, LLC, (operating during the inspection as Elutia, Inc. \u2013 Orthobiologics Business Unit, formerly Aziyo Biologics, Inc.), located at 880 Harbour Way S., Suite 100, Richmond, CA 94804, conducted between Septem",0,[1,2,16,18],"","",""],["2024-06-26","reBom Co., Ltd.",0,0,"","Mr. Kwangjeon Lee","rebom-co-ltd-682811-06262024","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our November 9, 2022, and February 26, 2024, requests for",0,[6,13,18],"3013693278","",""],["2024-06-25","AMCO International Manufacturing & Design, Inc.",2,2,"","Adam Milewski","amco-international-manufacturing-design-inc-681557-06252024","During an inspection of your firm located at 410 Conselyea Street, Brooklyn, NY on March 11, 2024, through March 20, 2024, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer of replacement batt",0,[18,20],"3005906887","",""],["2024-06-24","Ozempen.com",0,0,"","","ozempencom-684435-06242024","",1,[16,17,21],"3030805935","",""],["2024-06-21","Massachusetts Institute of Technology MIT",1,4,"","Dr. Leigh M. Firn MD","massachusetts-institute-technology-mit-663218-06212024","This Warning Letter informs you of objectionable conditions observed during a Food and Drug Administration (FDA) Remote Regulatory Assessment (RRA) of Massachusetts Institute of Technology (MIT) Committee on the Use of Humans as Experimental Subjects (COUHES)",0,[],"1282959","",""],["2024-06-18","Laboratorio Magnachem International",0,0,"","Federico M. Gomez","laboratorio-magnachem-international-673796-06182024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Laboratorio Magnachem International, FEI 3003320065, at Avenida Jose Francisco Pena, Esquina Calle K, Haina, San Cristobal, from November 7 to 10, 2023. This warning letter",0,[0,5,6,7,13,14,16,17,18],"3003320065","",""],["2024-06-18","Sun Pharmaceutical Industries Limited",0,0,"","Mr. Dilip Shanghvi","sun-pharmaceutical-industries-limited-677337-06182024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Sun Pharmaceutical Industries Limited, FEI 3004561553, at Survey No. 1012, Dadra-396 193, U.T. of Dadra and Nagar Haveli and Daman and Diu, from December 4 to 15, 2023. Thi",0,[3,7,14,18],"3004561553","",""],["2024-06-14","AG Essence, Inc.",2,2,"","Belkis Wingfield","ag-essence-inc-678344-06142024","During an inspection of your firm located at 5350 Lewis Rd, Ste E, Sandston, VA 23150 between January 9, 2024, and January 22, 2024, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer and distr",0,[17,18,20],"3009562273","",""],["2024-06-14","Vegewax Candleworx Ltd.",0,0,"","Suvil Parikh","vegewax-candleworx-ltd-675099-06142024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Vegewax Candleworx Ltd., FEI 3005787511, at 300 North Rivermede Rd., Concord, from October 16 to 19, 2023. This warning letter summarizes significant violations of Current",0,[7,13,14,18],"3005787511","",""],["2024-06-13","GFA Production Xiamen Co., Ltd.",0,0,"","Mr. Xusheng (Martin) Lin","gfa-production-xiamen-co-ltd-678364-06132024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, GFA Production Xiamen Co., Ltd., FEI 3008384335, at No. 20 Huli Industrial Park, Tong\u2019an District, Meixi Avenue, Xiamen, from December 4 to 8, 2023. This warning letter sum",0,[0,2,3,4,7,8,17,18],"3008384335","",""],["2024-06-12","Aqualex Co., Ltd.",0,0,"","Gee Ho Jang","aqualex-co-ltd-672292-06122024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Aqualex Co., Ltd., FEI 3010683345, at RM 203, 27, Dunchon-daero 457beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, Korea, from October 16 to 20, 2023. This warning letter s",0,[4,6,14,16,17,18],"3010683345","",""],["2024-06-12","Landy International",0,0,"","Mr. Yong (Roger) Ding","landy-international-679066-06122024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Landy International, FEI 3005698871, at No. 192-196, Tianfeng Road, Jimei District, Xiamen, from December 11 to 14, 2023. This warning letter summarizes significant violati",0,[0,6,13,18],"3005698871","",""],["2024-06-07","Angela D. Ritter, M.D.",0,0,"","","angela-d-ritter-md-681999-06072024","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between August 14 and August 17, 2023. Investigators Ann B. Borromeo and Matthew R. Coleman, repr",0,[],"3027391357","",""],["2024-06-05","Owlet Baby Care, Inc.",2,2,"","Mr. Kurt Workman","owlet-baby-care-inc-616354-06052024","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 616354, dated October 5, 2021). Based on our evaluation, it appears that you have addressed the violation(s) contained in th",0,[],"3012977166","",""],["2024-06-05","TCT Nutraceuticals SDN. BHD",0,0,"","Mr. Nurshakinah Mohd","tct-nutraceuticals-sdn-bhd-680743-06052024","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our June 16, 2022, and July 8, 2022, request for records",0,[5,6,13,18],"3017270745","",""],["2024-06-05","Yahon Enterprise Co., Ltd.",0,0,"","Mr. Hsu Ke Fu","yahon-enterprise-co-ltd-675592-06052024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Yahon Enterprise Co. Ltd., FEI 3017151342 at An Chu Hamlet, Tay Lac Village, Bac Son Commune, Trang Bom District, from December 15 to 21, 2023. This warning letter summariz",0,[3,4,6,13,14,18],"3017151342","",""],["2024-06-04","Fancystage Unipessoal, LDA",0,0,"","Mr. Pedro Branco","fancystage-unipessoal-lda-678453-06042024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Fancystage Unipessoal, Lda, FEI 3015282935, at Rua da Cumieira 31, Santiago Do Bougado Trofa, Porto, from January 22 to 26, 2024. This warning letter summarizes significant",0,[4,13,14,15,17,18,21],"3015282935","",""],["2024-05-29","Konrad Rejdak, M.D., Ph.D.",1,4,"","Konrad Rejdak, M.D., Ph.D.","konrad-rejdak-md-phd-671405-05292024","This Warning Letter informs you of objectionable conditions observed during a United States Food and Drug Administration (FDA) inspection conducted between May 15 and May 19, 2023. During the inspection, an FDA investigator met with you and your staff to revie",0,[0],"3025922936","",""],["2024-05-13","Aruba Aloe Balm N.V.",0,0,"","Mr. Koos Veel","aruba-aloe-balm-nv-674911-05132024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Aruba Aloe Balm N.V., FEI 3004117460, at Pitastraat 115, Oranjestad, from November 13 to 16, 2023. This warning letter summarizes significant violations of Current Good Man",1,[4,6,13,17,18],"3004117460","",""],["2024-05-09","Cue Health, Inc.",2,2,"","Mr. Clint Sever","cue-health-inc-675673-05092024","The Food and Drug Administration (FDA) conducted an inspection of your firm\u2019s medical device operations at Cue Health, Inc. (\u201cCue Health\u201d, \u201cyou\u201d, or \u201cyour firm\u201d) located at 4980 Carroll Canyon Rd Ste 100, San Diego, CA 92121-1736 on 10 dates between October 17",1,[17,18,20,21],"3016758165","",""],["2024-05-03","Natuzen Co., Ltd.",0,0,"2025-03-11","Mr. Seunghyun Cho","natuzen-co-ltd-677942-05032024","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our March 29, May 9, July 8, 2022, and October 6, 2023 re",1,[3,14,18],"3006731547","",""],["2024-05-02","Kevin R. Bender, M.D./DBC Research Corporation",0,0,"","Kevin R. Bender, M.D.","kevin-r-bender-mddbc-research-corporation-680072-05022024","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between December 5 and December 16, 2022. Investigator Angelica Chica, representing FDA, reviewed",1,[9],"3023815166","",""],["2024-04-30","Global Cosmetics Company Limited",0,0,"","Ms. Ranki Liu","global-cosmetics-company-limited-677948-04302024","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our September 12, 2022 request for records and other info",1,[6,13,14,18],"3013749236","",""],["2024-04-30","Grupo Quimico SRL",0,0,"","Mrs. Valeria Rivoir","grupo-quimico-srl-674010-04302024","The U.S. Food and Drug Administration (FDA) inspected your contract testing laboratory, Grupo Quimico SRL, FEI 3012281081, at Irlanda 2033, Montevideo, from November 20 to 22, 2023. This warning letter summarizes significant violations of Current Good Manufact",1,[0,5,6,7,14,18],"3012281081","",""],["2024-04-30","Ward Smelling Salts",0,0,"","Patrick Inglot","ward-smelling-salts-672166-04302024","This letter concerns your firm\u2019s distribution of over-the-counter (OTC) stimulant drug products. The U.S. Food and Drug Administration (FDA) has reviewed your website, (https://wardsmellingsalts.com/) and your social media account on Facebook, where your \u201dBOTT",1,[16,17,21],"3027888319","",""],["2024-04-24","Cardinal Health",2,2,"","Steve Mason","cardinal-health-679404-04242024","During an inspection of your firm Cardinal Health 200, LLC., located at 3651 Birchwood Dr., Waukegan, Illinois 60085 on December 11-20, 2023, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is an importer /ow",1,[13,17,18,20],"3001236905","",""],["2024-04-24","www.dashpct.com",0,0,"","","wwwdashpctcom-679727-04242024","",1,[16,17,21],"","",""],["2024-04-23","Jubilant Generics Limited",0,0,"","Dr. Jaidev Sanjeev Rajpal","jubilant-generics-limited-569799-04232024","",0,[],"3006895982","",""],["2024-04-18","Dr Sankunni\u2019s Ayurvedic Research Foundation Private Ltd.",0,0,"","Samantha Ross","dr-sankunnis-ayurvedic-research-foundation-private-ltd-678046-04182024","This letter concerns your firm\u2019s drug listing information provided to FDA\u2019s electronic Drug Registration and Listing System (eDRLS) for the following drug products: Relief Balm, NDC 70146-000; Womens Relief Balm, NDC 70146-001; Sports Balm, NDC 70146-002; Wome",1,[17],"3005939772","",""],["2024-04-18","Zen Enterprises LLC",0,0,"2024-09-17","David Makima","zen-enterprises-llc-678407-04182024","This letter concerns your firm\u2019s drug listing information provided to FDA\u2019s electronic Drug Registration and Listing System (eDRLS) for your drug products, Zen Sports Balm, NDC 73048-000, Zen Hemp Balm, NDC 73048-001, Zen Hand Sanitizer, NDC 73048-002, and Syc",1,[17],"3013828269","",""],["2024-04-17","Pinnacle Labs of Tennessee, LLC dba Pinnacle BioLabs",2,2,"","Charles E. Balentine","pinnacle-labs-tennessee-llc-dba-pinnacle-biolabs-676367-04172024","During an inspection of your firm, Pinnacle Labs of Tennessee, LLC dba Pinnacle BioLabs, located at 315 Deaderick Street, Suite 1550, Nashville, TN 37238-3003 on October 27, 2023, November 1, 2023, and November 3, 2023, an investigator from the United States F",1,[9,10,11,12,17,18,20],"3010982075","",""],["2024-04-11","C&T Dream Co., Ltd.",0,0,"","Mr. Tae Woo Anh","ct-dream-co-ltd-678300-04112024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, C&T Dream Co., Ltd., FEI 3012668529, at 60 Baekseokgongdan 7-Ro, Seobuk-gu, Cheonan-si, Chungcheongnam-do, Republic of Korea, from November 6 to 10, 2023. This warning lett",1,[4,13,18],"3012668529","",""],["2024-04-08","Natco Pharma Limited",0,0,"2025-09-29","Mr. Rajeev Nannapaneni","natco-pharma-limited-672564-04082024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Natco Pharma Limited, FEI 3004540906, at Kothur Village Rangareddy, Telangana, India, from October 9 to 18, 2023. This warning letter summarizes significant violations of C",1,[3,7,14,15,18],"3004540906","",""],["2024-04-05","Terragene S.A.",2,2,"","Mr. Esteban Lombardia","terragene-sa-667432-04052024","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter CMS case # 667432, dated November 01, 2023. Based on our evaluation, it appears that you have addressed the violation(s) contained",0,[],"3013145340","",""],["2024-04-03","FirstCham Co., Ltd.",0,0,"","Mr. Sang-Hoi Kim","firstcham-co-ltd-672903-04032024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, FirstCham Co., Ltd., FEI 3010970108, at 87, Geumil-ro, 700beon-Gil, Samseong-Myeon, Eumseong-gun, Chungcheongbuk-do, from October 23 to 27, 2023. This warning letter summar",1,[0,3,4,5,6,7,13,14,17,18],"3010970108","",""],["2024-04-03","Jiangsu Meifan Biotechnology Co. Ltd.",0,0,"","Linda Lee","jiangsu-meifan-biotechnology-co-ltd-676562-04032024","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our August 15, 2022 request for records and other informa",1,[14,18],"3017005720","",""],["2024-03-28","Kilitch Healthcare India Limited",0,0,"","Mr. Paresh Mehta","kilitch-healthcare-india-limited-672956-03282024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Kilitch Healthcare India Limited, FEI 3011853060, at R - 904 905 T T C Industrial Road, Navi Mumbai from October 12 to October 20, 2023. This warning letter summarizes sign",1,[0,1,2,3,6,7,8,14,15,18],"3011853060","",""],["2024-03-27","Bodywell Natural Skin Care Inc.",0,0,"","Mr. Richard Crombie","bodywell-natural-skin-care-inc-677099-03272024","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our February 8, 2023 request for records and other inform",1,[4,13,15,16,17,18],"3018011294","",""],["2024-03-25","Dermal Source, Inc.",0,14,"","Mary Jane Haake","dermal-source-inc-663632-03252024","This letter concerns your firm\u2019s distribution of the drug products, NEW & IMPROVED BLUE GEL, SUPERIOR SUPER JUICE, PREMIUM PRO PLUS, FIVE-STAR VASOCAINE, and MAXIMUM ZONE 1 for use as external analgesics prior to sensitive cosmetic procedures. The United State",1,[16,17],"3017200845","",""],["2024-03-25","Indelicare DBA INKEEZE",0,14,"","Brian Ether, CEO","indelicare-dba-inkeeze-671656-03252024","This letter concerns your firm\u2019s distribution of the drug products INK EEZE Original B NUMB NUMBING GEL, INK EEZE B NUMB NUMBING SPRAY BLACK LABEL and INK EEZE B NUMB NUMBING FOAM SOAP for use as external analgesics prior to sensitive cosmetic procedures. The",1,[16,17],"3015204327","",""],["2024-03-25","SeeNext Venture, Ltd.",0,14,"","Jung Woo Shin","seenext-venture-ltd-674915-03252024","This letter concerns your firm\u2019s distribution of the drug products NumbSkin 5% Lidocaine Numbing Cream (15 grams), NumbSkin 5% Lidocaine Numbing Cream (30 grams), and NumbSkin 10.56% Lidocaine Numbing Cream for use as external analgesics prior to sensitive cos",1,[16,17],"3028143571","",""],["2024-03-25","Sky Bank Media, LLC dba Painless Tattoo Cream Co.",0,14,"","Skylor Eli Burbank","sky-bank-media-llc-dba-painless-tattoo-cream-co-666693-03252024","This letter concerns your firm\u2019s distribution of the drug products, PAINLESS TATTOO NUMBING CREAM and PAINLESS TATTOO NUMBING SPRAY for use as external analgesics prior to sensitive cosmetic procedures. The United States Food and Drug Administration (FDA) revi",1,[16,17],"3028005436","",""],["2024-03-25","Tattoo Numbing Cream Co.",0,14,"","","tattoo-numbing-cream-co-672467-03252024","This letter concerns your firm\u2019s distribution of the drug products, SIGNATURE TATTOO NUMBING CREAM and MIRACLE NUMB SPRAY for use as external analgesics prior to sensitive cosmetic procedures. The United States Food and Drug Administration (FDA) reviewed your",1,[16,17],"3028008119","",""],["2024-03-25","TKTX Company",0,14,"","","tktx-company-673879-03252024","This letter concerns your firm\u2019s distribution of the drug products \u201cTKTX Numb MAXIMUM STRENGTH PAIN RELIEVER,\u201d \u201cMithra+ 10% Lidocaine,\u201d \u201cTKTX During Procedure Numbing Gel 40%,\u201d and \u201cJ-CAIN cream [LIDOCAINE] 29.9%\u201d for use as external analgesics prior to sensit",1,[16,17],"3027980112","",""],["2024-03-22","Antaria Pty. Ltd.",0,0,"","Mr. Geoffrey B. Acton","antaria-pty-ltd-674495-03222024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Antaria Pty. Ltd., FEI 3025978151, at 81 Shettleston St, Units 1 & 2 Rocklea, Queensland, Australia, from November 13 to 17, 2023. This warning letter summarizes significan",1,[5,6,7,14,18],"3025978151","",""],["2024-03-21","Agena Bioscience, Inc.",2,2,"","Roman Haehn","agena-bioscience-inc-665159-03212024","",1,[17,18,20],"3010962166","",""],["2024-03-21","Augustine Temperature Management, LLC",2,2,"","Scott D. Augustine","augustine-temperature-management-llc-671243-03212024","During an inspection of your firm located at 7656 W. 78th Street, Bloomington, MN 55439 on 09/06/2023 through 09/19/2023, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer of various class II",1,[10,11,13,17,18,20],"3005857264","",""],["2024-03-21","Betone S.A. de C.V.",0,0,"","Dr. Edith Parra de la Torre","betone-sa-de-cv-674299-03212024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Betone S.A. de C.V, FEI 3016998650, at Periferico Poniente #7100, Col. Ciudad Granja, Zapopan, Jalisco 45010, from November 6 to 10, 2023. This warning letter summarizes si",1,[6,13,18,21],"3016998650","",""],["2024-03-21","Bret R. Rutherford, M.D.",0,0,"","Bret R. Rutherford, M.D.","bret-r-rutherford-md-670544-03212024","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between December 19, 2022, and January 10, 2023. Investigators Omadevi Somai and Eileen Monaghan,",1,[0,9],"3023259471","",""],["2024-03-21","New York State Psychiatric Institute IRB",0,0,"","Corinne M. Rogers","new-york-state-psychiatric-institute-irb-670989-03212024","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted between January 23 and February 2, 2023, of the New York State Psychiatric Institute (NYSPI) Institutional Review Board",1,[],"2431841","",""],["2024-03-19","Ammonia Sport Inc.",0,0,"","Justin Rapoport","ammonia-sport-inc-672196-03192024","This letter concerns your firm\u2019s distribution of over-the-counter (OTC) stimulant drug products. The U.S. Food and Drug Administration (FDA) reviewed your website on November 2023 and March 2024 at the Internet address https://www.ammoniasport.com where your \"",1,[16,17,21],"3017370207","",""],["2024-03-18","Deqing Jiarou Daily Chemical Co., Ltd.",0,0,"","Huifang Mao","deqing-jiarou-daily-chemical-co-ltd-677928-03182024","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our September 12, 2022 request for records and other info",1,[6,13,14,18],"3013042669","",""],["2024-03-18","Jiangsu Shenli Medical Production Co., Ltd.",2,2,"","Liqun Yang","jiangsu-shenli-medical-production-co-ltd-677753-03182024","",1,[10,17,18,20],"3003902757","",""],["2024-03-18","Medline Industries, LP",2,2,"","James Boyle","medline-industries-lp-677545-03182024","During an inspection of your firm located at 3 Lakes Drive, Northfield, IL on December 11, 2023, through January 22, 2024, investigators from the United States Food and Drug Administration (FDA) determined that your firm is a specification developer and compla",1,[7,10,12,17,18,20],"1417592","",""],["2024-03-13","Skull Smash LLC",0,0,"","Steve Welch","skull-smash-llc-672714-03132024","This letter concerns your firm\u2019s distribution of over-the-counter (OTC) stimulant drug products. On November 16, 2023 the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address (https://www.skull-smash.com) and on November 20, 20",1,[16,17,21],"3029879389","",""],["2024-03-08","Spirochaete Research Labs, LLC aka Scitus Laboratory Products",0,0,"","Eric C. Ritter","spirochaete-research-labs-llc-aka-scitus-laboratory-products-674278-03082024","This letter concerns your firm\u2019s distribution of over-the-counter (OTC) stimulant drug products. \u201cATOMIC RHINO -(SMELLING SALTS)-,\u201d \u201cRED LINE ATOMIC RHINO -(SMELLING SALTS)-,\u201d \u201cMEGATON ATOMIC RHINO -(SMELLING SALTS)-,\u201d and \u201cMEGATON RED LINE ATOMIC RHINO -(SMEL",1,[16,17,21],"3023254292","",""],["2024-02-28","Native Salts LLC",0,0,"","Andrew J. Pickens","native-salts-llc-674277-02282024","This letter concerns your firm\u2019s distribution of an over-the-counter (OTC) stimulant drug product. The U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.nativesalts.com on November 15, 2023. We also reviewed your",1,[16,17,21],"3014651598","",""],["2024-02-27","Thai Nakorn Patana Co., Ltd.",0,0,"","Mr. Vinai Veerapuchong","thai-nakorn-patana-co-ltd-672712-02272024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Thai Nakorn Patana Co., Ltd., FEI 3003067499, at 14 Thanon Ngamowongwan Soi 8, Muenang Nonthaburi, Nonthaburi, from July 31 to August 4, 2023. This warning letter summarize",1,[3,4,14,18],"3003067499","",""],["2024-02-23","Royal Philips",2,2,"","Roy Jakobs","royal-philips-676605-02232024","During an inspection of your firm's manufacturing facility located in Suzhou, China on October 23, 2023, through October 26, 2023, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures Computed Tomograph",1,[4,17,18,20],"3009529630","",""],["2024-02-22","Innovative Formulations, LLC dba Insane Labz",0,0,"","John T Rozkiewicz, Owner","innovative-formulations-llc-dba-insane-labz-672952-02222024","This letter concerns your firm\u2019s distribution of an over-the-counter (OTC) stimulant drug product. The U.S. Food and Drug Administration (FDA) reviewed your website on November 14, 2023 at the Internet address https://www.insanelabz.com, and your Amazon storef",1,[16,17,21],"3010382813","",""],["2024-02-15","LightEyez Limited",0,0,"","Dr. Charlie Carmichael","lighteyez-limited-665450-02152024","The U.S. Food and Drug Administration (FDA) has obtained samples and conducted testing of \u201cLightEyez.com MSM Eye Drops v2.0 \u2013 Eye Repair\u201d (MSM Eye Repair Drops) ophthalmic drug product. This over-the-counter (OTC) drug product is labeled as and confirmed by yo",1,[7,16,18],"3027822577","",""],["2024-02-14","Amman Pharmaceutical Industries",0,0,"","Dr. Fadi Al-Atrash","amman-pharmaceutical-industries-668867-02142024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Amman Pharmaceutical Industries, FEI 3013501887, at Building 108, Street A3, King Abdullah II Industrial City, Amman, from August 7 to 15, 2023. This warning letter summari",1,[0,1,2,7,8,14,15,18],"3013501887","",""],["2024-02-13","Salvacion USA Inc.",0,0,"","Ryan S. Hwang","salvacion-usa-inc-672252-02132024","This letter concerns your firm\u2019s distribution of the drug product Covixyl Nasal Spray. 1 The U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://covixyl.com/ on October 10, 2023. On the same date, we also reviewed your",1,[16],"3017660889","",""],["2024-02-09","Human Microbes",1,4,"","Michael J. Harrop","human-microbes-672740-02092024","This is to advise you that the United States Food and Drug Administration (FDA) has reviewed your website at www.humanmicrobes.org in February 2024, which contains instructions on how to buy fecal microbiota for transplantation (FMT) (hereinafter, \u201cyour produc",1,[16,19],"3030000849","",""],["2024-02-09","ivsupplyclinic.com",0,0,"","","ivsupplycliniccom-672780-02092024","",1,[17],"","",""],["2024-02-07","Synthetix Inc. DBA Helix Chemical Supply",0,0,"","Matthew Lucks","synthetix-inc-dba-helix-chemical-supply-668918-02072024","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.helixchem.com in October 2023 and has observed that your website offers \u201cSemaglutide\u201d and \u201cTirzepatide\u201d products for sale i",1,[16,17,21],"3029095356","",""],["2024-02-07","US Chem Labs",0,0,"","","us-chem-labs-669074-02072024","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.uschemlabs.com in October 2023 and has observed that your website offers \u201cSemaglutide,\u201d \u201cTirzepatide\u201d and \u201cThymalin\u201d produc",1,[16,17,21],"3029137335","",""],["2024-02-06","Global Life Technologies Corp.",0,0,"","John Willimann","global-life-technologies-corp-674279-02062024","This letter concerns your firm\u2019s distribution of the over-the-counter (OTC) drug product Nozin\u00ae Nasal Sanitizer\u00ae. The U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.nozin.com/ on October 19 and October 20, 202",1,[16,17],"3007588545","",""],["2024-02-05","Ningbo Poplar Daily-Use",0,0,"","Mr. Gao Lingyan","ningbo-poplar-daily-use-669486-02052024","Your facility was registered with the U.S. Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our June 10, 2022, and June 24, 2022 request for records and othe",1,[6,13,17,18],"3019951059","",""],["2024-02-05","Sichuan Deebio Pharmaceutical Co. Ltd.",0,0,"","Mr. Zhang Ge","sichuan-deebio-pharmaceutical-co-ltd-669808-02052024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Sichuan Deebio Pharmaceutical Co. Ltd., FEI 3011139911, at 15 Gaocaocun, Xiaohanzhen, Guanghan, Deyang, Sichuan, from September 4 to September 8, 2023. This warning letter",1,[0,14,18],"3011139911","",""],["2024-02-02","Ehy Holdings, LLC",0,0,"","Jabez Liu","ehy-holdings-llc-675591-02022024","This letter concerns your firm\u2019s drug listing information provided to FDA\u2019s electronic Drug Registration and Listing System (eDRLS) for the following drug products 1 : 81799-001 Nicotine Transdermal Patches 81799-002 Nicotine Transdermal Patches 81799-003 Nico",1,[17],"3018499361","",""],["2024-02-01","Madhu Instruments Private Limited",0,0,"","Mr. Amit Gupta","madhu-instruments-private-limited-659694-02012024","The U.S. Food and Drug Administration (FDA) inspected your manufacturing facility, Madhu Instruments Private Limited FEI 3007317099, at A-260, Okhla Industrial Area, Phase-1, New Delhi, from October 11 to 21, 2022. FDA determined that (b)(4) manufactured at yo",1,[3,17,18],"3007317099","",""],["2024-01-31","Barkey GmbH & Co. KG",1,4,"2024-08-05","Christian Barkey","barkey-gmbh-co-kg-657073-01312024","During an inspection of your firm Barkey GmbH & Co. KG, located at Gewerbestr. 8, Leopoldshohe, North Rhine-Westphalia, 33818, Germany, conducted between October 31, 2022 and November 4, 2022, the United States Food and Drug Administration (FDA) documented tha",1,[12,17,18,20],"3006629881","",""],["2024-01-31","Les Importations Herbasant\u00e9 Inc.",0,0,"","Mr. Patrick Toledano","les-importations-herbasante-inc-668412-01312024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Les Importations Herbasant\u00e9 Inc., FEI 3003175217, at 377 Sainte-Croix Ave., Saint-Laurent, from August 14 to 18, 2023. This warning letter summarizes significant violations",1,[4,13,14,17,18],"3003175217","",""],["2024-01-29","Soulaire Corporation",2,2,"","Morad Soulati","soulaire-corporation-675069-01292024","The United States Food and Drug Administration (FDA) has learned that your firm, Soulaire Corporation, is marketing the External Counterpulsation (ECP) System Model: Soulaire, an external counter-pulsating device under 21 CFR 870.5225, in the United States wit",0,[17,18,19,20],"3017791225","",""],["2024-01-26","Nobles Medical Technology II, Inc.",2,2,"","Anthony A. Nobles, PhD","nobles-medical-technology-ii-inc-673465-01262024","This Warning Letter is to inform you of objectionable conditions observed during the Food and Drug Administration (FDA) inspection conducted at Nobles Medical Technology II, Inc. from October 16, 2023, to October 20, 2023, by investigators from the FDA\u2019s Offic",1,[0,11,20],"3002690289","",""],["2024-01-26","S & J International Enterprises Public Company Limited",0,0,"","Mr. Praj Srichandra","s-j-international-enterprises-public-company-limited-668482-01262024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, S & J International Enterprises Public Company Limited, FEI 3005979923, at 600/4 Moo.11 Sukaphiban 8 Road, Nongkharm, Si Racha, from July 17 to July 21, 2023. This warning",1,[0,7,14,15,18],"3005979923","",""],["2024-01-24","Sambrosa Care Inc.",0,0,"","John F.R. de Wit, Pharm.D.","sambrosa-care-inc-673321-01242024","This letter concerns your firm\u2019s distribution of the over-the-counter (OTC) combination antihistamine and nighttime sleep-aid drug product \u201cSambrosa sweet dreams Night Syrup.\u201d \u201cSambrosa sweet dreams Night Syrup\u201d is an unapproved new drug introduced or delivere",1,[16,17,21],"3018095920","",""],["2024-01-22","Mei Lan Thailand Co., Ltd.",0,0,"","Mrs. Lan Pu","mei-lan-thailand-co-ltd-672783-01222024","The U.S. Food and Drug Administration (FDA) notified your site, Mei Lan (Thailand) Co., Ltd., FEI 3012190301, at 35/252-253 Moo 2 , Tambol Bangnamched, Muang District, Muang Samut Sakhon, Samutsakorn, Thailand, of a planned inspection of your drug manufacturin",1,[17,18],"3012190301","",""],["2024-01-19","Exactech, Inc.",2,2,"","Darin B. Johnson","exactech-inc-669904-01192024","During an inspection of your firm located at 2320 NW 66th Court, Gainesville, Florida on 9/18/2023 through 9/26/2023, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer of Equinoxe aTSA and Equ",1,[9,11,12,17,18,20],"1038671","",""],["2024-01-18","Abraxis Bioscience LLC",0,0,"","Nathan Trembath","abraxis-bioscience-llc-633713-01182024","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter # 633713 dated October 31, 2022. Based on our evaluation, it appears that you have addressed the violation contained in this",0,[],"3006441852","",""],["2024-01-16","Glicerinas Industriales, S.A. de C.V.",0,0,"","Mr. Carlos Andres Gomez Rodriguez","glicerinas-industriales-sa-de-cv-665472-01162024","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Glicerinas Industriales, S.A. de C.V., FEI 3016420687, at Calle Uranio No. 80, Col. Arenales Tapatios, Zapopan, from May 8 to 12, 2023. This warning letter summarizes signi",1,[7,14,18],"3016420687","",""],["2024-01-08","Dr. Joel Kaplan Inc.",2,2,"2026-03-03","Mr. Shumuel Itshaki","dr-joel-kaplan-inc-667193-01082024","During an inspection of your firm, Dr. Joel Kaplan Inc. (DJK or \u201cthe firm\u201d), located in San Diego, CA, on June 27, 2023, through June 30, 2023, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a manufacture",1,[10,12,13,17,18,19,20],"3001890611","",""],["2024-01-04","Fresenius Kabi AG",2,2,"","Pierluigi Antonelli","fresenius-kabi-ag-671249-01042024","During an inspection of your firm, Fresenius Kabi USA, LLC, located at 50 High Street, Suite 50, North Andover, MA 01845-2620 on August 15, 2023, through September 7, 2023, an investigator from the United States Food and Drug Administration (FDA) determined th",1,[9,11,17,18,20],"3014732157","",""],["2023-12-28","Woorilife & Health",0,0,"","Ho Dong Yang","woorilife-health-672936-12282023","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over the counter (OTC) drug products. FDA has reviewed the records you submitted in response to our February 8, 2023, and July 12, 2023, requests for rec",0,[13,14,18],"3014653532","",""],["2023-12-26","Techlem Medical Corporation",2,2,"","Dr. Anurag Sinha, President","techlem-medical-corporation-671395-12262023","",1,[9,12,13,17,18,20],"3000134760","",""],["2023-12-21","Botanical Be",0,0,"","Edgar H. Felix","botanical-be-671066-12212023","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://botanical-be.com/ in July 2023, where you take orders for \u201cKuka Flex Forte,\u201d \u201cReumo Flex,\u201d and \u201cArtri King Reforzado co",0,[16,17,21],"3027716877","",""],["2023-12-20","Amazon.com, Inc.",0,9,"","Andy Jassy","amazoncom-inc-662503-12202023","This letter concerns your firm\u2019s distribution of products that violate the Federal Food, Drug, and Cosmetic Act (the \u201cFD&C Act\u201d). The United States Food and Drug Administration (FDA) purchased on your website, www.amazon.com, products that are labeled as energ",0,[16,17,21],"3016994737","",""],["2023-12-20","Hua Da Trading, Inc.",0,0,"","Daniel Zeng","hua-da-trading-inc-664359-12202023","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address, https://www.eshoponlineusa.com, from July to December 2023, where you take orders for \u201cWeFun.\u201d 1 In addition, FDA has obtained",0,[16,17,21],"3027553871","",""],["2023-12-20","MiMedx Group, Inc.",1,4,"","Joseph H. Capper","mimedx-group-inc-662942-12202023","During inspections of your MiMedx Group, Inc. (hereinafter, \u201cMiMedx\u201d) locations at 300 Town Park Dr NW Ste 260, Kennesaw, GA 30144, and 1775 W Oak Commons Court NE, Marietta, GA 30062, conducted between February 22, 2023 and March 2, 2023, the United States Fo",0,[2,4,14],"3009814715","",""],["2023-12-19","Jeffrey W. Taub, M.D./Children's Hospital of Michigan",0,0,"","Jeffrey W. Taub, M.D.","jeffrey-w-taub-mdchildrens-hospital-michigan-674545-12192023","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between September 23, 2022, and October 12, 2022. Investigators Jennifer A. Kemp and Andrace Deya",0,[9],"3023464259","",""],["2023-12-15","Patcos Cosmetics Pvt. Ltd.",0,0,"","Vimal Patel","patcos-cosmetics-pvt-ltd-669465-12152023","Your facility was registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products, including (b)(4) and (b)(4) . FDA has reviewed the records you submitted in response to our July 12, 2023 request",0,[13,14,18],"3009250196","",""],["2023-12-14","www.trinexpharmacy.com",0,0,"","","wwwtrinexpharmacycom-671351-12142023","",1,[16,17,21],"","",""],["2023-12-12","Anish S. Shah, M.D./Siyan Clinical Research",0,0,"","","anish-s-shah-mdsiyan-clinical-research-674073-12122023","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between December 5 and December 16, 2022. Investigator Kristin M. Abaonza, representing FDA, revi",0,[9],"3023890987","",""],["2023-12-07","Novid Group, Inc.",0,0,"","Marc Kerner","novid-group-inc-672251-12072023","This letter concerns your firm\u2019s distribution of the over-the-counter (OTC) combination antihistamine and nasal decongestant drug product novid NASAL SPRAY. 1 The United States Food and Drug Administration (FDA) reviewed your website on October 12, 2023 at the",1,[16,17],"3028011400","",""],["2023-12-04","Fresenius Medical Care AG & Co. KGaA",2,2,"","Helen Giza","fresenius-medical-care-ag-co-kgaa-666791-12042023","The United States Food and Drug Administration (FDA) conducted an inspection of your firm\u2019s medical device operations, Fresenius Medical Care Holdings, Inc. (Fresenius), d.b.a. Fresenius Care North America, located at 920 Winter Street, Building 920, Waltham,",0,[9,10,12,17,18,20],"3001451489","",""],["2023-12-04","Sonesta Medical AB",2,2,"","Pelin Sari","sonesta-medical-ab-667325-12042023","",0,[],"3010496070","",""],["2023-12-01","Belmont Eyecare LLC",0,0,"","Golie Keovan","belmont-eyecare-llc-670186-12012023","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet addresses https://www.chicagoashlandeyecare.com/ in October 2023. The FDA has observed that your website offers \u201cColloidal Silver Eye Drops,\u201d \u201cM",1,[16],"3029666082","",""],["2023-11-22","Dr. Berne\u2019s Whole Health Products",0,0,"","","dr-bernes-whole-health-products-665456-11222023","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://shop.drsamberne.com/ in August 2023. The FDA has observed that your website offers the products \u201cDr. Berne\u2019s MSM Eye Dr",1,[2,16,18],"3027822578","",""],["2023-11-21","Intas Pharmaceuticals Limited",0,0,"","Mr. Nimish Chudgar","intas-pharmaceuticals-limited-662868-11212023","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Intas Pharmaceuticals Limited, FEI 3003157498, at Plot No. 457- 458 & 191/218P, Sarkhej - Bavla Highway, Matoda - Sanand, Ahmedabad, from May 1 to May 12, 2023. This warnin",1,[0,1,2,4,7,8,14,15,18],"3003157498","",""],["2023-11-21","Professional Compounding Centers of America dba PCCA",0,0,"","Mr. Fabian V. Zaccardo","professional-compounding-centers-america-dba-pcca-597638-11212023","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-21-15 dated January 27, 2021. Based on our evaluation, it appears that you have addressed the violations contained in thi",0,[],"1629694","",""],["2023-11-17","AmLion Toothpaste Mfg. Sdn. Bhd.",0,0,"","Mr. Min Koon Koek","amlion-toothpaste-mfg-sdn-bhd-665879-11172023","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, AmLion Toothpaste Mfg. Sdn. Bhd., FEI 3006057298, at Lot 4, Gate A, Jalan Teknologi 3/6, Seksyn 3, Taman Sains Selangor, Petaling Jaya, Selangor, from July 10 to 14, 2023.",1,[3,4,6,13,14,15,18],"3006057298","",""],["2023-11-17","Cipla Limited",0,0,"","Mr. Umang Vohra","cipla-limited-660904-11172023","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Cipla Limited, FEI 3008581988, at Plot No. 9 & 10, Pharma Zone Phase II, Sector III, Indore Special Economic Zone, Pithampur, District Dhar, Madhya Pradesh 454775, India, f",1,[1,2,6,7,8,10,14,18],"3008581988","",""],["2023-11-17","Jiangsu NHWA Pharmaceutical Co., Ltd.",0,0,"","Weibing Wang","jiangsu-nhwa-pharmaceutical-co-ltd-582511-11172023","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-19-42 dated September 10, 2019. Based on our evaluation, it appears that you have addressed the deviations contained in t",0,[],"3005619485","",""],["2023-11-17","Nantong Furuida Packaging Products Co., Ltd.",0,0,"","Mr. Sunan Ge","nantong-furuida-packaging-products-co-ltd-667984-11172023","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our April 3, 2023 request for records and other informati",1,[6,13,18],"3015509579","",""],["2023-11-16","Cerci Kozmetik Ve Otel Ekipmanlari Pazarlama Ic Ve Dis Ticaret Limited Sirketi",0,0,"","Mr. Ahmet Turan Aydin","cerci-kozmetik-ve-otel-ekipmanlari-pazarlama-ic-ve-dis-ticaret-limited-sirketi-669488-11162023","Your facility is registered with the U.S. Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our June 16, 2022, and July 6, 2023 requests for records and other",1,[6,17,18],"3017978054","",""],["2023-11-16","Discover Health, LLC d/b/a Discover CBD and Strain Snobs",0,11,"","Justin L. Hays","discover-health-llc-dba-discover-cbd-and-strain-snobs-661488-11162023","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at https://discovercbd.com/ and https://www.activecbdoil.com from June to August 2023. We note that your firm is the U.S. distributor for the Active CBD Oil br",1,[16,17,18,19,20,21],"3016000795","",""],["2023-11-15","Xiamen Wally Bath Manufacture Co., Ltd.",0,0,"","Mr. Jackson Zhong","xiamen-wally-bath-manufacture-co-ltd-669407-11152023","Your facility is registered with the U.S. Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our June 15, 2022, July 5, 2022, and July 10, 2022 requests for re",1,[6,13,17,18],"3009675687","",""],["2023-11-13","Amazon.com, Inc.",0,0,"","Andrew Jassy","amazoncom-inc-665460-11132023","This letter concerns your firm\u2019s distribution of \u201cSimilasan Pink Eye Relief,\u201d \u201cThe Goodbye Company Pink Eye,\u201d \u201cCan-C Eye Drops,\u201d \u201cOptique 1 Eye Drops,\u201d \u201cOcluMed Eye Drops,\u201d \u201cTRP Natural Eyes Floaters Relief,\u201d and \u201cManzanilla Sophia Chamomile Herbal Eye Drops\u201d",0,[16,17,18],"3016994737","",""],["2023-11-13","Sudesan Temizlik Urunleri Ve Ambalaj Sanaryi Ticaret Anomin Sirketi",0,0,"","Mr. Kemal Deniz","sudesan-temizlik-urunleri-ve-ambalaj-sanaryi-ticaret-anomin-sirketi-666900-11132023","Your facility is registered with the U.S. Food and Drug Administration (FDA or Agency) as a manufacturer of over-the-counter (OTC) drug products, including Amoray Instant Hand Sanitizer. The FDA has reviewed the records you submitted on March 11, 2022, in resp",0,[5,6,13,18],"3004647124","",""],["2023-11-08","Melanie M. Hoppers, M.D./Physicians Quality Care",0,0,"","","melanie-m-hoppers-mdphysicians-quality-care-671684-11082023","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between December 6 and 15, 2022. Investigator Ann B. Borromeo, representing FDA, reviewed your co",1,[],"3023878838","",""],["2023-11-08","Wello Inc.",2,2,"2024-10-28","Mr. Alan C. Heller","wello-inc-664806-11082023","During an inspection of your firm located in Addison, Texas, on June 15 through June 21, 2023, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures (or markets) the welloStationX. Under section 201(h)",1,[17],"3011214569","",""],["2023-11-08","www.directpharmashop.net",0,0,"","","wwwdirectpharmashopnet-668345-11082023","",1,[16,17,21],"","",""],["2023-11-06","Saruhan Kimya Ve Temizlik Urunleri Sanayi Ticaret Anonim Sirketi Corlu Subesi",0,0,"","Mr. Suleyman Kutluay","saruhan-kimya-ve-temizlik-urunleri-sanayi-ticaret-anonim-sirketi-corlu-subesi-669487-11062023","Your facility is registered with the U.S. Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our June 14, 2022, July 12, 2022, and July 28, 2023 requests for r",1,[6,13,17,18],"3018310083","",""],["2023-11-01","Terragene S.A.",2,2,"","Mr. Esteban Lombardia","terragene-sa-667432-11012023","During an inspection of your firm located in Alvear, Santa Fe, Argentina on June 06, 2023 through June 09, 2023, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures and distributes Biological and Che",0,[2,10,11,17,18,20],"3013145340","",""],["2023-10-31","Acrostak Schweiz AG",2,2,"","Mr. Youri G. Popowski","acrostak-schweiz-ag-668948-10312023","During an inspection of your firm located in Winterthur, Switzerland on June 12, 2023, through June 15, 2023, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the M-Cath Microcatheter and M-Cath F",1,[4,11,12,17,18,20],"3005086865","",""],["2023-10-30","Dexterity Health, LLC DBA Zazzee Naturals",0,0,"","Eric Posnack","dexterity-health-llc-dba-zazzee-naturals-667898-10302023","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your product listings on your Amazon storefront at https://www.amazon.com/s?me=A1TFTEC4OJXXG4&marketplaceID=ATVPDKIKX0DER in September 2023. The FDA has observed that your A",1,[16],"3013768283","",""],["2023-10-27","Neurotris, Inc. dba A1 Engineering",2,2,"","Anthony \u201cTony\u201d E. Picciano","neurotris-inc-dba-a1-engineering-659244-10272023","During an inspection of your firm, Neurotris, Inc. (Neurotris or NeurotriS or \u201cthe firm\u201d), located in Irvine, CA, on April 4, 2023, through April 25, 2023, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a",1,[9,12,17,18,20,21],"3008069988","",""],["2023-10-25","Dexcowin Co. Ltd.",2,2,"","Raymond Ryu","dexcowin-co-ltd-545388-10252023","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letters (CMS Case No. 545388, dated February 20, 2018, and CMS Case No. 474468, dated August 11, 2015). Based on our evaluation, it appear",0,[],"3007065358","",""],["2023-10-24","Abbott Laboratories",1,7,"2025-01-21","Robert B. Ford","abbott-laboratories-669353-10242023","This is to advise you that the United States Food and Drug Administration (FDA) has reviewed your company\u2019s websites at www.abbottnutrition.com, www.abbott.com, and www.pediatricproconnect.com in October 2023 and your company\u2019s marketing materials for Similac\u00ae",1,[16,18,19,20],"1513768","",""],["2023-10-23","Nortec Quimica SA",0,0,"","Mr. Marcelo C. Mansur","nortec-quimica-sa-639894-10232023","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-23-07 dated December 8, 2022. Based on our evaluation, it appears that you have addressed the deviations contained in thi",0,[],"3007616930","",""],["2023-10-20","Global Pharma Healthcare Private Limited",0,0,"","Dr. A.R. Venkatesh","global-pharma-healthcare-private-limited-657325-10202023","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Global Pharma Healthcare Private Limited, FEI 3012323885, at A-9 SIDCO Pharmaceutical Complex, Thiruporur, from February 20 to March 2, 2023. This warning letter summarizes",1,[1,2,17,18],"3012323885","",""],["2023-10-20","Maria W. Greenwald, M.D.",0,0,"","","maria-w-greenwald-md-670580-10202023","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between October 17 and October 27, 2022. Investigator Sherri N. Rohlf, representing FDA, reviewed",1,[],"3002960047","",""],["2023-10-20","Samm Solutions, Inc., d.b.a. BTS Research",0,0,"","Usama M. Abunadi","samm-solutions-inc-dba-bts-research-663898-10202023","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted between June 27 and July 8, 2022. Investigator Theressa B. Smith, representing FDA, reviewed the role of Samm Solutions",1,[9],"3006252706","",""],["2023-10-16","Sun Pharmaceutical Industries Ltd.",0,0,"","Mr. Dilip Shanghvi","sun-pharmaceutical-industries-ltd-636199-10162023","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Sun Pharmaceutical Industries Ltd., FEI 3002809586, at Halol-Baroda Highway, Dist. Panchmahal, Halol 389350, Gujrat, India, from April 26 to May 9, 2022. This warning lette",0,[1,2,3,8,14,15,18],"3002809586","",""],["2023-10-13","ReNovo, Inc. DBA Provision Device Reprocessing Solutions",2,2,"","Kirk M. Mansberger","renovo-inc-dba-provision-device-reprocessing-solutions-664014-10132023","During an inspection of your firm located at 340 SW Columbia St., Bend, OR on May 15, 2023 through May 18, 2023, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a reprocessor and distributor of reprocessed",1,[2,17,18,20],"3014023545","",""],["2023-10-04","Handock Cosmetics Co., Ltd.",0,0,"","Mr. Sang Eui Lee","handock-cosmetics-co-ltd-658737-10042023","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Handock Cosmetics Co., Ltd., FEI 3007295883, at 19 Eunbong-ro, Namdong-gu, Incheon 21634, from March 20 to March 24, 2023. This warning letter summarizes significant violat",1,[7,13,14,16,17,18],"3007295883","",""],["2023-10-02","Neitz Instruments Company Ltd.",2,2,"","Ms. Takae Nishizawa","neitz-instruments-company-ltd-664336-10022023","The United States Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 664336, dated August 25, 2023). Based on our evaluation, it appears that you have addressed the violation(s) c",0,[],"3002807701","",""],["2023-10-02","Seoul Cosmetics Co., Ltd.",0,0,"","Mr. Jung Soo Han","seoul-cosmetics-co-ltd-653882-10022023","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Seoul Cosmetics Co., Ltd., FEI 3007253462, at 12, Namdongdong-ro 63beon-Gil, Namdong-gu, from January 30 to February 3, 2023. This warning letter summarizes significant vio",1,[4,6,13,14,16,17,18],"3007253462","",""],["2023-10-02","www.gorillahealing.com",0,0,"","","wwwgorillahealingcom-664245-10022023","",1,[16,17,21],"","",""],["2023-10-02","www.semaspace.com",0,0,"","","wwwsemaspacecom-665848-10022023","",1,[16,17,21],"","",""],["2023-09-29","www.alphamedstore.com",0,0,"","","wwwalphamedstorecom-665889-09292023","",1,[16,17,21],"","",""],["2023-09-28","Infinant Health, Inc formerly Evolve Biosystems Inc.",1,17,"","Michael D. Johnson","infinant-health-inc-formerly-evolve-biosystems-inc-667715-09282023","This is to advise you that the United States Food and Drug Administration (FDA) has reviewed your company\u2019s website at www.evivo.com in September 2023 and your marketing materials, including your Evivo with MCT Oil Product Information sheet, which contains dir",0,[16,18,19,20],"3012767995","",""],["2023-09-26","Antonio E. Blanco, M.D./Vista Health Research, LLC",0,0,"","","antonio-e-blanco-mdvista-health-research-llc-668519-09262023","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between January 11 and January 30, 2023. Investigator Richard A. Lyght, representing FDA, reviewe",1,[9],"3015928879","",""],["2023-09-25","Shot of Joy LLC",0,0,"","James B. Carty","shot-joy-llc-665936-09252023","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://shotofjoy.com/ in September 2023 and determined that you take orders there for various Shot of Joy brand kratom and kava products, including \u201cClassic",0,[16],"3027955125","",""],["2023-09-22","Sonesta Medical AB",2,2,"","Pelin Sari","sonesta-medical-ab-667325-09222023","During an inspection of your firm located in Solna, Sweden on June 5, 2023, through June 7, 2023, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Model 6210 radiographic table and Model S2 an",0,[10,11,12,13,18,20],"3010496070","",""],["2023-09-20","Getsch+Hiller Medizintechnik GmbH",2,16,"","Mr. Werner M. Hiller","getschhiller-medizintechnik-gmbh-644680-09202023","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS#644680, dated December 27, 2022). Based on our evaluation, it appears that you have addressed the violation(s) contained in th",0,[],"3008911114","",""],["2023-09-20","Luis Javier Pena-Hernandez, M.D., FCCP",0,0,"","","luis-javier-pena-hernandez-md-fccp-668217-09202023","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between January 9 and January 23, 2023. Investigator Emily A. (Green) Baldwin, representing FDA,",0,[],"3024611819","",""],["2023-09-19","Hygienic Labs, LLC",0,0,"","Neil Sargisian","hygienic-labs-llc-667816-09192023","Your firm is registered with the United States Food and Drug Administration (FDA or Agency) as a manufacturer of over-the-counter (OTC) drug products; specifically, products listed included (b)(4) . On September 27, 2022, the FDA sent an electronic request for",1,[],"3017242852","",""],["2023-09-19","P.T. Sankei Medical Industries",2,2,"","Yoshinori Koyama","pt-sankei-medical-industries-665754-09192023","During an inspection of your firm located in Banten, Indonesia on May 8, 2023, through May 11, 2023, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Sphygmomanometer Unit (Adult and Large Adu",1,[9,11,12,17,18,20],"3001576493","",""],["2023-09-18","Zhao Qing Longda Biotechnology Co. Ltd.",0,0,"","Elben","zhao-qing-longda-biotechnology-co-ltd-664934-09182023","Your firm was registered with the United States Food and Drug Administration (FDA or Agency) as a manufacturer of over-the-counter (OTC) drug products, including toothpaste for children. Ingredients of the drugs registered as manufactured at your firm include",0,[17,18],"3014354419","",""],["2023-09-14","Maison Blanche LLC",0,0,"","Ms. Natalie Naifeh","maison-blanche-llc-666943-09142023","Your firm is registered with the United States Food and Drug Administration (FDA or Agency) as a manufacturer of over-the-counter (OTC) drug products; specifically, products listed include Hand Sanitizer N\u00ba93 Maison Blanche. On August 16, 2022, the FDA sent an",0,[],"3017125078","",""],["2023-09-12","Gulf States International, Inc.",0,0,"","Mr. Bret Holmes","gulf-states-international-inc-666918-09122023","Your firm is registered with the United States Food and Drug Administration (FDA or Agency) as a manufacturer of over-the-counter (OTC) drug products; specifically, products listed include (b)(4) . On September 9, 2022, the FDA sent an electronic request for r",0,[],"3007520648","",""],["2023-09-12","Walgreen Company",0,0,"","Elena Kraus","walgreen-company-662158-09122023","This letter concerns your firm\u2019s drug listing information provided to FDA\u2019s electronic Drug Registration and Listing System (eDRLS) for your drug product, Walgreens Sensitive Extra Whitening, NDC 0363-1588. 1 Your firm has not fulfilled its listing obligations",0,[17,21],"1460851","",""],["2023-09-11","Boiron, Inc.",0,0,"","Janick Boudazin","boiron-inc-663402-09112023","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.boironusa.com/ in July 2023. We also reviewed your social media websites at https://www.facebook.com/BoironUSA and https://w",0,[16,17,18],"3004351878","",""],["2023-09-11","CVS Health",0,0,"","Karen S. Lynch","cvs-health-663246-09112023","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.cvs.com in July 2023. The FDA has observed that your website offers \u201cCVS Health Pink Eye Relief Drops\u201d for sale in the United States",0,[16,17,18],"1217081","",""],["2023-09-11","DR Vitamins, LLC dba DR Vitamin Solutions",0,0,"","Jonathan Formby","dr-vitamins-llc-dba-dr-vitamin-solutions-663127-09112023","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.drvitaminsolutions.com in July 2023. We have also reviewed your social media websites at https://twitter.com/DRVitamins and www.face",0,[16,17,19],"3027582427","",""],["2023-09-11","Natural Ophthalmics, Inc.",0,0,"","Linda Axelrod","natural-ophthalmics-inc-663758-09112023","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://natoph.com/ in August 2023. The FDA has observed that your website offers \u201cWomen\u2019s Tear Stimulation Dry Eye Drops,\u201d \u201cAllergy Des",0,[16,17,18],"3010171880","",""],["2023-09-11","OcluMed LLC",0,0,"","","oclumed-llc-663525-09112023","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://oclumed.com/ in July 2023. The FDA has observed that your website offers \u201cOcluMed Nutritional/Lubricant Eye Drops\u201d (hereinafter",0,[16],"3027605575","",""],["2023-09-11","Similasan AG",0,0,"","Urs Lehmann","similasan-ag-658878-09112023","",0,[1,2,7,14,16,17,18],"1000110034","",""],["2023-09-11","TRP Company, Inc",0,0,"","Thomas Pominville","trp-company-inc-663037-09112023","As previously communicated to you in September 2022, your \u201cDryness Relief,\u201d \u201cPink Eye Relief,\u201d 1 \u201cAllergy Eyes Relief,\u201d \u201cRed Eye Relief,\u201d \u201cEye Strain Relief,\u201d \u201cEye Lid Relief,\u201d \u201cAging Eye Relief,\u201d \u201cBlur Relief,\u201d \u201cFloaters Relief,\u201d \u201cTwitching Relief,\u201d and \u201cStye",0,[16,17,18],"3013501887","",""],["2023-09-11","Walgreens Boots Alliance, Inc.",0,0,"","Stefano Pessina","walgreens-boots-alliance-inc-663404-09112023","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.walgreens.com in August 2023. The FDA has observed that your website offers \u201cWalgreens Allergy Eye Drops,\u201d \u201cWalgreens Stye Eye Drops",0,[16,17,18],"1460851","",""],["2023-09-05","BYD Precision Manufacture Co., Ltd",2,2,"","Liu Xiaoling","byd-precision-manufacture-co-ltd-666250-09052023","During an inspection of your firm located in Shenzhen, Guangdong, China on May 22, 2023 through May 26, 2023, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures BYD Surgical Mask Model FE2111, BYD S",0,[4,11,12,17,18,20],"3009545790","",""],["2023-08-31","Caltag Medsystems Ltd",2,2,"","Tim Almond, PhD","caltag-medsystems-ltd-662115-08312023","During an inspection of your firm located in Buckingham, United Kingdom on May 2 through May 4, 2023, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the TransFix/EDTA Vacuum Blood Collection Tub",1,[4,9,12,15,18,20,21],"3003315146","",""],["2023-08-25","Neitz Instruments Company Ltd.",2,2,"","Ms. Takae Nishizawa","neitz-instruments-company-ltd-664336-08252023","During an inspection of your firm located in Ichibancho, Japan on May 15, 2023, through May 19, 2023, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Neitz Halogen Ophthalmoscope BXa, 13A Under s",0,[10,11,17],"3002807701","",""],["2023-08-23","Green Pharmaceutical Co. Ltd.",0,0,"","Jang Hyun-pill","green-pharmaceutical-co-ltd-663544-08232023","Your facility was registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our March 3, 2023 request for records and other informat",0,[13,14,18],"3013338037","",""],["2023-08-21","Invacare Corporation",2,2,"","Geoffrey P. Purtill","invacare-corporation-617319-08212023","The Food and Drug Administration has completed evaluation of your firm\u2019s corrective actions in response to our Warning Letter WL # 617319 dated November 18, 2021. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Wa",0,[],"1000220413","",""],["2023-08-18","Amazon.com, Inc",0,0,"","Andrew Jassy","amazoncom-inc-649056-08182023","This letter concerns your firm\u2019s distribution of products intended to treat molluscum contagiosum and sold on your website, www.amazon.com. As discussed further below, your firm is responsible for introducing or delivering for introduction into interstate comm",0,[16,17,18],"3016994737","",""],["2023-08-18","Lydia Co Ltd.",0,0,"","Ho Dong Yang","lydia-co-ltd-659646-08182023","The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 2575. Based on our evaluation, it appears that you have addressed the violations contained in the warning letter and corrected th",0,[],"3015301033","",""],["2023-08-18","Molluscumaway LLC",0,0,"","Erica Groussman","molluscumaway-llc-650100-08182023","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://molluscumaway.com/ in July 2023. We also reviewed your social media websites at https://www.facebook.com/MolluscumAway",1,[16],"3025796097","",""],["2023-08-18","MolluscumRx, Inc.",0,0,"","Frank Almeida","molluscumrx-inc-648457-08182023","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://molluscumrx.com in June 2023. We also reviewed your social media websites, https://www.facebook.com/molluscumrx, https:",1,[16],"3015387681","",""],["2023-08-18","Nature\u2019s Innovation, Inc.",0,0,"","William S. Carlson","natures-innovation-inc-648560-08182023","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.naturasil.com in July 2023. We also reviewed your social media websites at www.instagram.com/naturasil/ and www.facebook.co",1,[16,17,18],"3007963810","",""],["2023-08-18","Thrasio, LLC D/B/A ZymaDerm",0,0,"","Greg Greeley","thrasio-llc-dba-zymaderm-649788-08182023","This letter is to advise you that, on May 11, 2023, the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://naturopathix.com, which appears on the container label and packaging of your product \u201cZymaDerm for Mo",1,[16,17,18],"3025765197","",""],["2023-08-18","Walmart, Inc",0,0,"","Doug McMillon","walmart-inc-648620-08182023","This letter concerns your firm\u2019s distribution of the \u201cNaturasil Molluscum Treatment Kit,\u201d a product intended to treat molluscum contagiosum, sold on your website www.walmart.com. As discussed below, your firm is responsible for introducing or delivering for in",1,[16,17,18],"3014706754","",""],["2023-08-16","King Systems Corp. dba Ambu, Inc.",2,2,"2025-06-16","Steven Block","king-systems-corp-dba-ambu-inc-661617-08162023","During an inspection of your firm, King Systems Corp., dba Ambu, Inc., located at 15011 Herriman Blvd, Noblesville, IN 46060 on two days from May 15, 2023 through May 16, 2023, investigators from the United States Food and Drug Administration (FDA) determined",1,[17,18,20],"1824226","",""],["2023-08-14","K. Boeun Pharmaceutical Co., Ltd.",0,0,"","Yoon Ki Jung","k-boeun-pharmaceutical-co-ltd-665099-08142023","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our March 3, 2023 request for records and other informati",1,[13,14,18],"3016756938","",""],["2023-08-11","Cosmobeauti Laboratories & Manufacturing Inc.",0,0,"","Ms. Barbara T. Choi","cosmobeauti-laboratories-manufacturing-inc-657682-08112023","The U.S. Food and Drug Administration inspected your drug manufacturing facility, Cosmobeauti Laboratories & Manufacturing Inc., FEI 3003921470, at 480 East Arrow Highway San Dimas, California, from March 6, 2023 to March 15, 2023. This warning letter summariz",1,[0,3,4,6,14,15,18],"3003921470","",""],["2023-08-09","CalmCo LLC previously named Ketomi LLC",0,0,"","Keith Page","calmco-llc-previously-named-ketomi-llc-663668-08092023","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.coliccalm.com in May 2023. The FDA has observed that your firm offers \u201cColic Calm,\u201d and \u201cColic Calm +,\u201d for sale in the Uni",1,[16,17,18],"3020678722","",""],["2023-08-08","Angela M. Stupi, M.D.",0,0,"","","angela-m-stupi-md-665471-08082023","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between September 1 and September 29, 2022. Investigator Cynthia L.. Rakestraw, representing FDA,",1,[9],"3022938366","",""],["2023-08-08","International Laboratories Corp. Ltd.",0,0,"","Arniruj Shinaprapha","international-laboratories-corp-ltd-664352-08082023","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our March 17, 2023 request for records and other informat",1,[13,14,18],"3006403166","",""],["2023-08-07","Laavo Clean, S.A. de C.V.",0,0,"","Mr. Diego Vel\u00e1zquez","laavo-clean-sa-de-cv-646574-08072023","Your firm is registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic hand rub drug product (also referred to as a consumer hand sanitizer), labeled as Instant Hand Sanitizer LaavoClean wit",0,[15,18],"3017301021","",""],["2023-08-04","Cergomex Imports, LLC",0,0,"","Mr. Victor Hugo Cerrillo Gonzalez","cergomex-imports-llc-664362-08042023","Your firm is registered with the United States Food and Drug Administration (FDA or Agency) as a manufacturer of over-the-counter (OTC) drug products; specifically, products including Sanetto Hands Sanitizer Gel. On August 16, 2022, the FDA sent an electronic",0,[],"3017539604","",""],["2023-08-04","GTP International Corp",0,0,"","Mr. Vu Tran","gtp-international-corp-664367-08042023","Your firm is registered with the United States Food and Drug Administration (FDA or Agency) as a manufacturer of over-the-counter (OTC) drug products; specifically, products including (b)(4) Hand Sanitizer. On August 16, 2022, the FDA sent an electronic reques",0,[],"3012495223","",""],["2023-08-03","Avaria Health & Beauty Corp.",0,0,"","Juston Sharratt","avaria-health-beauty-corp-663507-08032023","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our January 25, 2023 request for records and other inform",0,[13,14,18],"3014583374","",""],["2023-08-03","Daxal Cosmetics Private Limited",0,0,"","Daxal Desai","daxal-cosmetics-private-limited-663658-08032023","Your firm was registered with the United States Food and Drug Administration (FDA or Agency) as a manufacturer of over-the-counter (OTC) drug products including toothpaste. Ingredients of the drugs registered as manufactured at your firm include ingredients su",0,[17,18],"3006127560","",""],["2023-08-03","Fancystage Unipessoal, LDA",0,0,"","Teresa Neves","fancystage-unipessoal-lda-657341-08032023","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our March 17, 2023 request for records and other informat",0,[13,14,18],"3015282935","",""],["2023-08-03","KM Pharmaceutical Co. Ltd.",0,0,"","IL MO Kang","km-pharmaceutical-co-ltd-663522-08032023","Your firm is registered with the United States Food and Drug Administration (FDA or Agency) as a manufacturer of over-the-counter (OTC) drug products, including (b)(4) and hand sanitizer. Ingredients of the drugs registered as manufactured at your firm include",0,[17,18],"3010164172","",""],["2023-08-03","LCC Ltd.",0,0,"","Yoo Hoon","lcc-ltd-657336-08032023","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our March 3, 2023 request for records and other informati",0,[13,14,18],"3007255059","",""],["2023-08-03","Orchid Lifesciences",0,0,"","Smit Patel Managing","orchid-lifesciences-663478-08032023","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our January 25, 2023 request for records and other inform",0,[13,14,18],"3015154915","",""],["2023-08-03","Sangleaf Pharm., Co. Ltd.",0,0,"","Mr. Doo Hyun Yang","sangleaf-pharm-co-ltd-663495-08032023","Your firm was registered with the United States Food and Drug Administration (FDA or Agency) as a manufacturer of over-the-counter (OTC) drug products, including toothpaste for children. Ingredients of the drugs registered as manufactured at your firm include",0,[17,18],"3012845410","",""],["2023-08-03","Skyline Herbals Private Limited",0,0,"","Vikram Vakil","skyline-herbals-private-limited-663659-08032023","Your firm was registered with the United States Food and Drug Administration (FDA or Agency) as a manufacturer of over-the-counter (OTC) drug products including toothpaste. Ingredients of the drugs registered as manufactured at your firm include ingredients su",0,[17,18],"3017104669","",""],["2023-08-03","Suhan Aerosol",0,0,"","Saket Mhatre","suhan-aerosol-663489-08032023","Your facility was registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our January 25, 2023 request for records and other infor",0,[13,14,18],"3016067439","",""],["2023-08-03","Tan Alize Kozmetik Ve Temizlik Urunleri",0,0,"","Latife Nesrin Ozdemir","tan-alize-kozmetik-ve-temizlik-urunleri-659854-08032023","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our April 13, 2023 request for records and other informat",0,[13,14,18],"3004135088","",""],["2023-07-28","Intas Pharmaceuticals Limited",0,0,"","Mr. Nimish Chudgar","intas-pharmaceuticals-limited-652067-07282023","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Intas Pharmaceuticals Limited, FEI 3004011473, at Plot No. 5 To 14, Pharmez, Near Village Matoda, Sarkhej-Bavla National Highway No. 8-A, Taluka, Sanand, India, from Novemb",0,[0,4,7,8,14,15,18],"3004011473","",""],["2023-07-27","Mylan Laboratories Limited Unit 8, a Viatris Company",0,0,"","Mr. Scott A. Smith","mylan-laboratories-limited-unit-8-viatris-company-589297-07272023","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-20-06 dated November 5, 2019. Based on our evaluation, it appears that you have addressed the deviations contained in thi",0,[],"3002785310","",""],["2023-07-25","Baxter Healthcare Corporation",0,0,"","Mr. Jos\u00e9 E. Almeida","baxter-healthcare-corporation-654136-07252023","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Baxter Pharmaceuticals India Pvt. Ltd., 3004610460, at Village Vasana Chacharwadi, Taluka Sanand, Ahmedabad, India, from January 19 to January 27, 2023. This warning letter",0,[3,4,7,14,18],"3004610460","",""],["2023-07-25","Centaur Pharmaceuticals Private Ltd.",0,0,"","Mr. Shashikant Sonaje","centaur-pharmaceuticals-private-ltd-655231-07252023","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Centaur Pharmaceuticals Private Ltd., FEI 3008861619, at Plot No.4, International Biotech Park, Phase-II, Hinjewadi, Pune, Maharashtra, India from January 30 to February 8,",0,[3,5,6,7,14,18],"3008861619","",""],["2023-07-24","Kumar Organic Products Limited",0,0,"","Mr. K. K. Singh","kumar-organic-products-limited-598683-07242023","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-20-34 dated April 23, 2020. Based on our evaluation, it appears that you have addressed the violations contained in this",0,[],"3009167769","",""],["2023-07-21","Gadget Island, Inc.",0,0,"","Naeem Azizian","gadget-island-inc-658733-07212023","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address, www.gearisle.com, between January and July 2023, where you took orders for \u201cNUX Male Enhancement,\u201d \u201cDYNAMITE Male Sexual Enhan",0,[16,17,21],"3012263900","",""],["2023-07-20","Cantronic Systems Inc.",2,2,"","James Zahn","cantronic-systems-inc-613542-07202023","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 613542, dated March 4, 2021). Based on our evaluation, it appears that you have addressed the violations contained in this W",0,[],"3004054706","",""],["2023-07-20","CreativeStar Solutions",2,2,"","Steven Gao","creativestar-solutions-613535-07202023","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 613535, dated March 4, 2021). Based on our evaluation, it appears that you have addressed the violations contained in this W",0,[],"3018071928","",""],["2023-07-20","Dubak Electrical Group",2,2,"","Nebojsa \u201cNick\u201d Dubak","dubak-electrical-group-613511-07202023","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 613511, dated March 4, 2021). Based on our evaluation, it appears that you have addressed the violations contained in this W",0,[],"3014204295","",""],["2023-07-20","Medgel Private Limited",0,0,"","Alok K. Garg","medgel-private-limited-654085-07202023","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Medgel Private Limited, FEI 3010165392, at Plot No.: 19-20, Special Economic Zone, Phase-II, Sector-III, Pithampur, Dist. Dhar (M.P.), India, from January 23 to 27, 2023. T",0,[0,7,13,14,15,18],"3010165392","",""],["2023-07-20","Omega Engineering Inc.",2,2,"","Christine Riggs","omega-engineering-inc-613560-07202023","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 613560, dated March 4, 2021). Based on our evaluation, it appears that you have addressed the violations contained in this W",0,[],"3014540585","",""],["2023-07-20","Omnisense Systems Pte Ltd",2,2,"","Leonard Lim","omnisense-systems-pte-ltd-613561-07202023","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS #613561, dated March 4, 2021). Based on our evaluation, it appears that you have addressed the violations contained in this Wa",0,[],"3016626146","",""],["2023-07-20","Opgal Optronic Industries Ltd.",2,2,"","Eran Bluestein","opgal-optronic-industries-ltd-613562-07202023","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 613562, dated March 4, 2021). Based on our evaluation, it appears that you have addressed the violations contained in this W",0,[],"3017132984","",""],["2023-07-20","Shenzhen Sunell Technology Corporation",2,2,"","Ann Wu","shenzhen-sunell-technology-corporation-613563-07202023","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 613563, dated March 4, 2021). Based on our evaluation, it appears that you have addressed the violations contained in this W",0,[],"3017179586","",""],["2023-07-20","Wise Women\u2019s Choice",0,0,"","Lauren Love","wise-womens-choice-658897-07202023","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed the labeling of your product, \u201cWise Women\u2019s Choice,\u201d as of May 2023, including your website at https://wisebirthcontrol.com and your social media website at https:/",0,[16],"3027306194","",""],["2023-07-05","Outset Medical, Inc.",2,2,"","Ms. Leslie L. Trigg","outset-medical-inc-656485-07052023","",0,[17,18,20],"3010355846","",""],["2023-07-03","Sunshine Trading Company, Inc. dba Nova Tea and Nova Kratom",0,0,"","Joshua Miller","sunshine-trading-company-inc-dba-nova-tea-and-nova-kratom-660633-07032023","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.novakratom.com in June 2023 and have determined that you take orders there for kratom products such as varieties of Red Vein Kratom, White Vein Kratom, G",0,[16],"3027398816","",""],["2023-06-26","Lydia Co. Ltd.",0,0,"","Ho Dong Yang","lydia-co-ltd-659646-06262023","The United States Food and Drug Administration (FDA) has reviewed your firm\u2019s drug listing information provided to FDA\u2019s electronic Drug Registration and Listing System (eDRLS) for your drug products, Hot Pap Cataplasma (NDC 72988-0007), Amuldy Sports Gel (NDC",0,[17],"3015301033","",""],["2023-06-22","Suprimo Imports",0,0,"","Humberto Cecena","suprimo-imports-657631-06222023","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://suprimoimports.com/, in January and April 2023, where you took orders for \u201cAK Forte\u201d and \u201cBob Marley CannaKing.\u201d In add",0,[11,16,17,21],"3017531807","",""],["2023-06-20","Chengdu KeCheng Fine Chemicals Co., Ltd.",0,0,"","Mr. Ye","chengdu-kecheng-fine-chemicals-co-ltd-659389-06202023","Your firm was registered with the United States Food and Drug Administration (FDA or Agency) as a manufacturer of several active pharmaceutical ingredients (APIs). A review of import records showed multiple shipments of API into the U.S. which declared Chengdu",0,[17,18],"3014675751","",""],["2023-06-14","Randy J. Epstein, M.D./Chicago Cornea Consultants, Ltd.",0,0,"","Randy J. Epstein, M.D.","randy-j-epstein-mdchicago-cornea-consultants-ltd-658917-06142023","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between September 19 and October 26, 2022. Investigators Colleen E. Burke and Lisa Hayka, represe",0,[],"3002686308","",""],["2023-06-12","Vitang Technology LLC",2,2,"","Ronald Jiang","vitang-technology-llc-653455-06122023","During an inspection of your firm, Vitang Technology LLC. (Vitang or \u201cthe firm\u201d), located in Tustin, CA on January 24, 2023 through January 31, 2023, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a manuf",0,[4,9,10,13,17,18,20],"3015549533","",""],["2023-06-12","Warrior Labz SARMS",0,0,"","Jeremy Brown","warrior-labz-sarms-655280-06122023","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://warriorlabzsarms.com/ in May 2023 and has observed that you take orders there for products marketed on your firm\u2019s webs",0,[16],"3026850357","",""],["2023-06-05","Centaur Pharmaceuticals Private Ltd.",0,0,"","Mr. Shreekant Dattatraya Sawant","centaur-pharmaceuticals-private-ltd-651080-06052023","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Centaur Pharmaceuticals Private Ltd., FEI 3003973520, at Plot No. 75, 76 & 76/1, Chikhloli MIDC, Ambernath-West, Thane \u2013 421501, Maharashtra, from November 14 to November 2",0,[0,3,14,18],"3003973520","",""],["2023-06-02","GPT Pharmaceuticals Private Ltd",0,0,"","Mr. Ashok Adityan","gpt-pharmaceuticals-private-ltd-590938-06022023","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-20-13 dated December 17, 2019. Based on our evaluation, it appears that you have addressed the violations contained in th",0,[],"3008311641","",""],["2023-06-01","Ming Fai Industrial Co LTD",2,2,"","Mr. Tsz Kin Kent Yim","ming-fai-industrial-co-ltd-660075-06012023","During an inspection of your firm, located in Shenzhen, China, on March 06, 2023, through March 10, 2023, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures ultrasound gel and probe cover products.",1,[2,3,4,18,20],"3003340745","",""],["2023-05-31","Mobeen Mazhar, M.D.",0,0,"","Mobeen Mazhar, M.D.","mobeen-mazhar-md-660335-05312023","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between March 22 and April 28, 2022. Investigator Andrea A. Branche, representing FDA, reviewed y",0,[],"3021539793","",""],["2023-05-25","iRhythm Technologies, Inc.",2,2,"","Mr. Quentin S. Blackford","irhythm-technologies-inc-643474-05252023","",0,[9,10,17,18,20,21],"3021769057","",""],["2023-05-23","Strides Pharma Science Limited",0,0,"","Mr. Arun Kumar","strides-pharma-science-limited-576722-05232023","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-19-28 dated July 1, 2019. Based on our evaluation, it appears that you have addressed the violations contained in this Wa",0,[],"3012448465","",""],["2023-05-22","citypharma.us",0,0,"","","citypharmaus-657459-05222023","",0,[16,17,21],"","",""],["2023-05-19","I.T.S. GmbH",2,2,"","Mag. Wolfgang Auf","its-gmbh-657885-05192023","During an inspection of your firm located in Lassnithohe, Steiermark, 8301 on January 16, 2023, through January 19, 2023, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures bone fixation devices and o",0,[9,11,17,18],"3004369035","",""],["2023-05-19","Steiner Biotechnology, LLC",2,2,"","Gregory G. Steiner, DDS","steiner-biotechnology-llc-651802-05192023","During inspections of your firm located at 1051 Olsen Street, Suite 3611, Henderson, NV 89011 on August 15\u201319, 2022 and November 3-8, 2022, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures bone graf",0,[2,4,8,12,13,17,18,20],"3005138409","",""],["2023-05-18","Champaklal Maganlal Homeo Pharmacy Private Limited",0,0,"","Dhaval Kapadia","champaklal-maganlal-homeo-pharmacy-private-limited-656743-05182023","This letter is to advise you that the United States Food and Drug Administration (FDA) has determined that your firms manufacture, import, and/or distribute \u201cBebelyn Diarrhea\u201d and \u201cBebelyn Colic,\u201d and that these products are unapproved new drugs under section",0,[13,16,17,18],"3008874708","",""],["2023-05-18","Unimicro Medical Systems Shenzhen Co., Ltd.",2,2,"","Roly Lee","unimicro-medical-systems-shenzhen-co-ltd-624560-05182023","The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #624560 dated 01/06/2022. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Le",0,[],"3010806467","",""],["2023-05-12","Keshava Organics Private Ltd.",0,0,"","Mr. Dinkar K. Raut","keshava-organics-private-ltd-540146-05122023","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-18-41 dated March 15, 2018. Based on our evaluation, it appears that you have addressed the deviations contained in this",0,[],"3003677831","",""],["2023-05-11","Future Diagnostics Solutions B.V.",2,2,"","Mr. Frank Martel","future-diagnostics-solutions-bv-653493-05112023","",1,[9,11,12,17,18,20],"","",""],["2023-05-03","Mentor Worldwide LLC",2,2,"","Alenka Brzulja","mentor-worldwide-llc-573520-05032023","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS Case# 573520, dated March 18, 2019). Based on our evaluation, it appears that you have addressed the violation(s) contained in",0,[],"1000124389","",""],["2023-05-01","Indoco Remedies Limited",0,0,"","Suresh G. Kare","indoco-remedies-limited-575313-05012023","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-19-29 dated July 9, 2019. Based on our evaluation, it appears that you have addressed the violations contained in this Wa",0,[],"3006644152","",""],["2023-04-27","Tager Online, Inc. DBA Volt Candy; Volt Candy Wholesale Club",0,0,"","Ibrahim El Shahawy","tager-online-inc-dba-volt-candy-volt-candy-wholesale-club-652780-04272023","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.voltcandy.com, between December 2022 and March 2023, where you took orders for \u201cPrimeZEN Black 6000.\u201d 1 In addition, we obs",0,[16,17,21],"3025403089","",""],["2023-04-25","Medtronic MiniMed, Inc.",2,2,"","Geoff Martha","medtronic-minimed-inc-617539-04252023","The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated December 9, 2021. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Fut",0,[],"3003166194","",""],["2023-04-24","Nose Slap LLC",0,0,"","Daniel Schofield","nose-slap-llc-654566-04242023","This letter concerns your firm\u2019s distribution of over-the-counter (OTC) stimulant drug products. \u201cNOSE SLAP\u201d and \u201cSOUL SLAP\u201d drug products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of section 505(a)",0,[16,17,21],"3025627251","",""],["2023-04-19","Medolife Rx D/B/A MedoLife Corp., AELIA, Inc. and Quanta Inc.",0,0,"","Arthur G. Mikaelian","medolife-rx-dba-medolife-corp-aelia-inc-and-quanta-inc-651522-04192023","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at the Internet addresses www.medolife.com and www.medoliferx.com in April 2023. The FDA has observed that your websites offer \u201cEscozine-HP,\u201d \u201cEscozine Immunap",0,[16,17,18],"3006640241","",""],["2023-04-19","Sorcerz.com",0,0,"","","sorcerzcom-656021-04192023","",0,[16,17,21],"3026975400","",""],["2023-04-13","Pharmaplast S.A.E.",0,0,"","Mr. Wassim Attia","pharmaplast-sae-648883-04132023","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Pharmaplast S.A.E., FEI 3003767891, at Amria Free Zone, 30 Beside Lord International Factory Building, Alexandria from November 6 to November 10, 2022. This warning letter",0,[3,13,18],"3003767891","",""],["2023-04-10","Champaklal Maganlal Homeo Pharmacy Private Limited",0,0,"","Mr. Dhaval Kapadia","champaklal-maganlal-homeo-pharmacy-private-limited-652319-04102023","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) and homeopathic drug products. FDA has reviewed the records you submitted in response to our November 15, 2022 request for records",0,[13,17,18],"3018725547","",""],["2023-04-06","Zermat International S.A. de C.V.",0,0,"","Mr. Adelfo Enriquez Rios","zermat-international-sa-de-cv-647232-04062023","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Zermat Internacional S.A. de C.V., FEI 3003659249, at Calle Lazaro Cardenas No. 47, Unidad Habitacional San Jeronimo, Tepetlacalco, Tlalnepantla De Baz, from October 10 to",0,[0,4,6,7,10,14,18],"3003659249","",""],["2023-03-27","Procter & Gamble Manufactura S. de R.L. de C.V.",0,0,"","Maria Petry","procter-gamble-manufactura-s-de-rl-de-cv-650837-03272023","The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 2496. Based on our evaluation, you have discontinued the product listing by adding an end marketing date to the drug listing data",0,[],"3002744909","",""],["2023-03-22","Tyrone L. McCall, M.D./Cornea Associates of Texas",0,0,"","Tyrone L. McCall, M.D.","tyrone-l-mccall-mdcornea-associates-texas-651261-03222023","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted between September 12 and 19, 2022. Investigator Joanne M. Schlossin, representing FDA, reviewed the role of Cornea Asso",0,[],"3020491814","",""],["2023-03-16","www.ivermectin4covid.com",0,0,"","","wwwivermectin4covidcom-650184-03162023","",0,[16,17,21],"","",""],["2023-03-15","Olympus Medical Systems Corp.",2,2,"","Mr. Seiji Morishita","olympus-medical-systems-corp-654013-03152023","During an inspection of your firm located in Tokyo, Japan on November 7, 2022, through November 10, 2022, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures endoscopes and endoscope accessories incl",0,[2,4,9,10,11,17,18,20],"3003637092","",""],["2023-03-14","Procter & Gamble Manufactura S. de R.L. de C.V.",0,0,"","Gail Burke","procter-gamble-manufactura-s-de-rl-de-cv-650837-03142023","The United States Food and Drug Administration (FDA) has reviewed your firm\u2019s drug listing information provided to FDA\u2019s electronic Drug Registration and Listing System (eDRLS) for your drug product, Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion,",0,[17,21],"3002744909","",""],["2023-03-14","Robert J. Hayashi, M.D./Washington University School of Medicine, Department of Pediatrics",0,0,"","Robert J. Hayashi, M.D.","robert-j-hayashi-mdwashington-university-school-medicine-department-pediatrics-654873-03142023","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between June 23, 2022, and July 8, 2022. Investigator Carmen Y. Fisher, representing FDA, reviewe",0,[9],"3022205731","",""],["2023-03-10","Skin Sheek",2,2,"","Meredith Dodini Hult","skin-sheek-612682-03102023","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 612682, dated January 28, 2022). Based on our evaluation, it appears that you have addressed the violation(s) contained in t",0,[],"3016035303","",""],["2023-03-09","Cutera, Inc.",2,2,"","David H. Mowry","cutera-inc-639552-03092023","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 639552, dated November 10, 2022). Based on our evaluation, it appears that you have addressed the violation(s) contained in",0,[],"3002900199","",""],["2023-03-07","Samchundang Pharm Co., Ltd.",0,0,"","Mr. In-Seok Chun","samchundang-pharm-co-ltd-599255-03072023","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-20-35 dated May 13, 2020. Based on our evaluation, it appears that you have addressed the deviations contained in this Wa",0,[],"3008425092","",""],["2023-03-03","Maggie Jeffries, M.D. / Avanti Anesthesiology, LLC",0,0,"","Maggie Jeffries, M.D.","maggie-jeffries-md-avanti-anesthesiology-llc-646498-03032023","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between July 19 and August 5, 2021. Investigator Andrea A. Branche, representing FDA, reviewed yo",0,[],"3017155458","",""],["2023-03-02","ElectRx and Health Solutions, LLC",0,0,"","","electrx-and-health-solutions-llc-614251-03022023","",0,[16,17,18,21],"","",""],["2023-02-21","Sooil Development Co., Ltd.",2,2,"","Jin-Seok Noh","sooil-development-co-ltd-607127-02212023","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 607127, dated April 16, 2020). Based on our evaluation, it appears that you have addressed the violation(s) contained in thi",0,[],"3003024060","",""],["2023-02-13","Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil",0,0,"","Ms. Gulten Erdemir","delta-kozmetik-sanayi-ve-ticaret-selim-yesil-645478-02132023","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil, FEI 3010166780, at Bolgesi Aydinli Sb Mahallesi, 6 12 Istanbul Endustri Veticaret Serbest, Sokak Tuzla, Istanbul, from Septemb",0,[4,6,13,18],"3010166780","",""],["2023-02-13","Medivance Instruments Ltd.",2,2,"","Mr. Sidney Grant","medivance-instruments-ltd-647562-02132023","During an inspection of your firm located in Harlesden, London, United Kingdom on August 8, 2022, through August 11, 2022, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Velopex Aquacut Flui",0,[9,10,11,17,18,20],"3003982003","",""],["2023-02-09","Aurobindo Pharma Limited",0,0,"","Mr. K. Nithyananda Reddy","aurobindo-pharma-limited-577033-02092023","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-19-27 dated June 20, 2019. Based on our evaluation, it appears that you have addressed the deviations contained in this W",0,[],"3004611182","",""],["2023-02-08","Cutera, Inc.",2,2,"2024-10-18","David H. Mowry","cutera-inc-639552-02082023","The United States Food and Drug Administration (FDA) completed an evaluation of your firm's corrections and corrective actions in response to our Warning Letter (CMS # 639552, dated November 10, 2022). We address your response below, in relation to each of the",1,[17,18,20],"3002900199","",""],["2023-02-08","Pfizer Healthcare India Private Limited",0,0,"","Mr. Albert Bourla","pfizer-healthcare-india-private-limited-594972-02082023","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-20-31 dated March 25, 2020. Based on our evaluation, it appears that you have addressed the violations contained in this",0,[],"3008316085","",""],["2023-02-06","The Body Bean, LLC",0,0,"","Malin R. Sickelton","body-bean-llc-649817-02062023","The United States Food and Drug Administration (FDA) has reviewed your firm\u2019s drug registration and listing information provided to FDA\u2019s electronic Drug Registration and Listing System (eDRLS) for your drug product, The Body Bean\u2019s Hand Sanitizer - Scented. O",0,[17],"3025764508","",""],["2023-02-06","USA Medical LLC",2,2,"","Damon Roberts","usa-medical-llc-631500-02062023","",0,[],"3021504509","",""],["2023-02-03","Fischer Analysen Instrumente Gmbh",2,2,"","Dr. Martin Schaich","fischer-analysen-instrumente-gmbh-650388-02032023","During an inspection of your firm located in Leipzig, Germany on November 1, 2022 through November 4, 2022, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the PyloPlus UBT System 13/12 CO 2 brea",0,[9,10,11,17,18,20],"3010837197","",""],["2023-01-31","Alchymars ICM SM Private Limited",0,0,"","Mr. K. Nagaradjan","alchymars-icm-sm-private-limited-542879-01312023","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-18-35 dated February 16, 2018. Based on our evaluation, it appears that you have addressed the deviations contained in th",0,[],"3005216842","",""],["2023-01-31","Malladi Drugs & Pharmaceuticals Ltd.",0,0,"","Mr. V.N. Gopalkrishnan","malladi-drugs-pharmaceuticals-ltd-541915-01312023","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-18-40 dated March 09, 2018. Based on our evaluation, it appears that you have addressed the deviations contained in this",0,[],"3005115135","",""],["2023-01-30","Fei Fah Medical Manufacturing Pte. Ltd.",0,0,"","Mr. Lawrence Lau Chief","fei-fah-medical-manufacturing-pte-ltd-633084-01302023","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our May 18, 2021, request for records and other informati",1,[5,6,13,18],"3003892002","",""],["2023-01-30","Monkeypox-treatment.com",0,0,"","Eric Sminia","monkeypox-treatmentcom-644773-01302023","This letter is to advise you that on October 31, 2022, the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.monkeypox-treatment.com. While reviewing your website, FDA observed that you participate in the Amazon",0,[16,17,19,21],"3024549692","",""],["2023-01-30","Old Tiles Wallpaper, LLC DBA Old Tiles Decor",0,0,"","Rozan Kitchen","old-tiles-wallpaper-llc-dba-old-tiles-decor-643920-01302023","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address, www.oldtilesdecor.com, on October 11, 2022, and observed that your website offers \u201cWind River Skin Comfort Blend,\u201d \u201cWind River",0,[16,17,21],"3024359859","",""],["2023-01-23","Laboratoires Clarins",0,0,"","Mr. Jonathan Zrihen","laboratoires-clarins-568157-01232023","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-19-20 dated April 23, 2019. Based on our evaluation, it appears that you have addressed the violations contained in this",0,[],"3002759467","",""],["2023-01-18","Buzzagogo, LLC",0,0,"","","buzzagogo-llc-639545-01182023","This letter is to advise you that the United States Food and Drug Administration (FDA) has reviewed your product labeling, including on your website at the Internet address https://buzzagogo.com/, in August 2022 and has determined that you take orders there fo",0,[2,16,17,18],"3012197003","",""],["2023-01-11","CTX Lifesciences Private Ltd.",0,0,"","Mr. Kanak J. Jariwala","ctx-lifesciences-private-ltd-577416-01112023","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-19-30 dated July 12, 2019. Based on our evaluation, it appears that you have addressed the deviations contained in this W",0,[],"3006254924","",""],["2023-01-11","Larkin Community Hospital Institutional Review Board",0,0,"","(b)(6)","larkin-community-hospital-institutional-review-board-638146-01112023","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted between November 12 and November 19, 2021, of the Larkin Community Hospital Institutional Review Board (IRB). Investiga",0,[],"1000113240","",""],["2023-01-10","HIS Enterprise Inc dba Adam\u2019s Secret USA, LLC",0,0,"","Kwang Pyo Lee","his-enterprise-inc-dba-adams-secret-usa-llc-646494-01102023","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.adamssecret.com, in May 2022 and again in December 2022, where you take orders for \u201cAdam\u2019s Secret Extra Strength 3000 Plati",0,[16,17,21],"3018094463","",""],["2023-01-10","Medical Mikes, Inc.",0,0,"","Mike Vanacoro","medical-mikes-inc-647603-01102023","",0,[16,17,19],"3025180991","",""],["2023-01-10","Purecraft LLC",0,0,"","Jason Navarrete","purecraft-llc-648077-01102023","",0,[16,17,19],"3011328724","",""],["2023-01-09","Distributor RFR, LLC",0,0,"","Mr. Roger L. Flores","distributor-rfr-llc-643724-01092023","The U.S. Food and Drug Administration (FDA) inspected your facility located in Doral, FL, on June 2-3, 7, 10, and 14, 2022. FDA obtained a sample and labeling of your product \u201cSANGTER Natural Male Energy Supplement\u201d (hereinafter \u201cSANGTER Energy Supplement\u201d) du",0,[16,17,21],"3014001652","",""],["2023-01-06","pharmahealthonline.com",0,0,"","","pharmahealthonlinecom-648510-01062023","",0,[16,17,21],"","",""],["2023-01-05","PharmaCanna",0,0,"","Johnny H. Meier","pharmacanna-647390-01052023","",0,[16,17,19],"3025183167","",""],["2022-12-29","Turkuaz Sa\u011flik Hizmetleri Medikal Temizlik Kimyasa",2,2,"2025-07-21","Mehmet Kayaba\u015f","turkuaz-saglik-hizmetleri-medikal-temizlik-kimyasa-649158-12292022","During an inspection of your firm located in Esenyurt-Istanbul, Turkey, on September 19, 2022, through September 23, 2022, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures ultrasound gel products.",1,[9,10,11,12,13,18,20],"3009482034","",""],["2022-12-27","Getsch+Hiller Medizintechnik GmbH",2,2,"","Mr. Werner M. Hiller","getschhiller-medizintechnik-gmbh-644680-12272022","During an inspection of your firm located in Tuttlingen, Nendingen, Germany on July 18, 2022 through July 21, 2022, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Monopolar Laparoscopic Instrume",0,[2,12,17,18,20],"3008911114","",""],["2022-12-27","North American Diagnostics, LLC",2,2,"","Elizabeth A. Lashinsky","north-american-diagnostics-llc-643203-12272022","The United States Food and Drug Administration (FDA) conducted an inspection of your firm\u2019s medical device operations, North American Diagnostics, LLC (\u201cNorth American,\u201d \u201cyou,\u201d or \u201cyour firm\u201d), located at 618 Ridgewood Ave, Suite 100, Holly Hill, Florida on fi",0,[4,9,11,12,17,18,19,20],"3021477751","",""],["2022-12-22","Primus Corporation dba Trinity Biotech",2,2,"","Ronan O'Caoimh","primus-corporation-dba-trinity-biotech-607698-12222022","The Food and Drug Administration has completed evaluation of your firm's corrective actions in response to our Warning Letter (CMS # 607698) issued on August 11, 2020. Based, on our evaluation, it appears that you have addressed the violations contained in the",0,[],"1931251","",""],["2022-12-21","Unit Dose Services, LLC",0,0,"","Peter Levasseur","unit-dose-services-llc-636177-12212022","The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 2310. Based on our evaluation, it appears that you have addressed the violations contained in this warning letter and corrected t",0,[],"3010164341","",""],["2022-12-20","Rite Aid Corporation",0,0,"","Elizabeth Hanlon","rite-aid-corporation-643207-12202022","The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 2277. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter and corrected t",0,[],"3024210457","",""],["2022-12-16","Superior Glove Works, Ltd.",0,0,"","Mr. Tony Geng","superior-glove-works-ltd-641100-12162022","Your facility was registered with the United States Food and Drug Administration (FDA or Agency) as a manufacturer of over-the-counter (OTC) drug products, including consumer antiseptic hand rub drug products (also referred to as consumer hand sanitizers), unt",0,[13,15,17,18],"3006217765","",""],["2022-12-14","Adarsh Daswani, M.D.",0,0,"","","adarsh-daswani-md-648606-12142022","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between October 18 and October 29, 2021. Investigators Dustin R. Abaonza and Yuanyuan Li, represe",0,[9],"3017716431","",""],["2022-12-12","Olympus Medical Systems Corporation",2,2,"","Tomohisa Sakurai","olympus-medical-systems-corporation-649726-12122022","During an inspection of your firm located in Hachioji-shi, Tokyo, Japan, on September 6, 2022, through September 9, 2022, an investigator (or investigators) from the United States Food and Drug Administration (FDA) determined that your firm manufactures gastro",0,[11,17],"3002807795","",""],["2022-12-08","Nortec Quimica SA",0,0,"","Mr. Marcelo C. Mansur","nortec-quimica-sa-639894-12082022","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Nortec Quimica SA, FEI 3007616930, at Rua Dezessete, 200, Distrito Industrial, Xerem, Duque de Caxias, Rio de Janeiro from July 18 to 22, 2022. This warning letter summariz",0,[0,5,7,14,15,18],"3007616930","",""],["2022-12-07","Centrient Pharmaceuticals India Private Limited",0,0,"","Mr. Manoj Sharma","centrient-pharmaceuticals-india-private-limited-640196-12072022","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Centrient Pharmaceuticals India Private Limited, FEI 3004497364, at Bhai Mohan Singh Nagar, Toansa, Dist. SBS Nagar (Nawanshahr), Punjab from June 23 to July 1, 2022. This",0,[0,3,7,8,14,18],"3004497364","",""],["2022-12-05","Thriftmaster Texas, LLC. d/b/a ThriftMaster Global Holdings, Inc. and TM Global Biosciences, LLC",0,9,"","Steven Haynes","thriftmaster-texas-llc-dba-thriftmaster-global-holdings-inc-and-tm-global-biosciences-llc-641057","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at www.cedarcreekdistributors.com, www.thriftmasterholdings.com, and https://apelindx.com in November 2022 and has determined that you take orders there for va",0,[3,16,17,18,19,20,21],"","",""],["2022-11-29","Hetero Labs Limited Unit V",0,0,"","Mr. P. R. Bhaskar Reddy","hetero-labs-limited-unit-v-520359-11292022","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-17-46 dated August 15, 2017. Based on our evaluation, it appears that you have addressed the violations contained in this",0,[],"3008307735","",""],["2022-11-28","AG Hair Limited",0,0,"","Mr. Graham Fraser","ag-hair-limited-638646-11282022","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, AG Hair Limited, FEI 3002892007, at 14 King Edward Street, Coquitlam from June 20 to 24, 2022. This warning letter summarizes significant violations of Current Good Manufac",0,[2,10,13,18],"3002892007","",""],["2022-11-22","Glenmark Pharmaceuticals Limited",0,0,"","Mr. Glenn Saldanha","glenmark-pharmaceuticals-limited-637314-11222022","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Glenmark Pharmaceuticals Limited, FEI 3004672766 at Plot No. S-7, Colvale Industrial Estate, Colvale, Bardez, Goa from May 12, 2022 to May 20, 2022. This warning letter sum",0,[4,5,7,15,18],"3004672766","",""],["2022-11-18","\"David M. Lubeck, M.D./Arbor Centers for EyeCare",0,0,"","David M. Lubeck, M.D.","david-m-lubeck-mdarbor-centers-eyecare-643531-11182022","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between April 12 and April 20, 2022. Investigator Yuanyuan Li, representing FDA, reviewed your co",0,[],"3015595236","",""],["2022-11-18","RoyalVibe Health Ltd.",2,2,"","Dr. Raymond L. Venter","royalvibe-health-ltd-639553-11182022","During an attempted inspection of your firm located in the Woodlands, TX on June 17, 2022 through July 5, 2022, an investigator from the United States Food and Drug Administration (FDA) determined that your firm markets, distributes and manufactures the CellQu",0,[17,18,19,20],"3022074304","",""],["2022-11-16","QLRAD Netherlands",2,2,"","Arjen Winkel","qlrad-netherlands-510526-11162022","",0,[],"3006948745","",""],["2022-11-14","goodimmuno.com",0,0,"","","goodimmunocom-642697-11142022","",0,[16,17,21],"","",""],["2022-11-14","yourtramadol.com",0,0,"","","yourtramadolcom-639959-11142022","",0,[16,17,21],"","",""],["2022-11-08","Abbott Point of Care Canada Limited",2,2,"","Edward O\u2019Neill","abbott-point-care-canada-limited-640946-11082022","During an inspection of your firm located in Ottawa, Canada on May 16, 2022, through May 19, 2022, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the i-STAT cTnI Test intended for the quantitati",0,[12,17,18,20],"3005643513","",""],["2022-11-03","The Anthos Group, Inc.",0,0,"","Mr. Shan Umer","anthos-group-inc-636846-11032022","Your firm is registered with the United States Food and Drug Administration (FDA or Agency) as a manufacturer of over-the-counter (OTC) drug products; specifically, products including VERTRA Hand Sanitizer. On December 4, 2020, the FDA sent an electronic reque",1,[],"3016861323","",""],["2022-11-03","Zydus Lifesciences Limited",0,0,"","Dr. Shavril Patel","zydus-lifesciences-limited-584856-11032022","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-20-05 dated October 29, 2019. Based on our evaluation, it appears that you have addressed the violations contained in thi",0,[],"3002984011","",""],["2022-11-02","Aizu Olympus Co., Ltd.",2,2,"","Yasuo Takeuchi","aizu-olympus-co-ltd-643172-11022022","During an inspection of your firm located in Aizuwakamatsu, Fukushima, Japan, on July 5, 2022, through July 8, 2022, an investigator (or investigators) from the United States Food and Drug Administration (FDA) determined that your firm manufactures sterile and",0,[4,11,12,17,18,20],"3002964398","",""],["2022-11-01","Alternative Health Distribution LLC d/b/a CannaAid",0,0,"","Lee Vantine, III","alternative-health-distribution-llc-dba-cannaaid-641241-11012022","",1,[16,17,19],"3023804081","",""],["2022-10-31","Abraxis Bioscience LLC",0,0,"2024-03-25","Mr. Giovanni Caforio","abraxis-bioscience-llc-633713-10312022","The U.S. Food and Drug Administration inspected your drug manufacturing facility, Abraxis Bioscience, LLC, FEI 3006441852, at 620 N 51st Ave., Phoenix, AZ from March 28 to April 6, 2022. This warning letter summarizes significant violations of Current Good Man",1,[1,2,7,14,18],"3006441852","",""],["2022-10-31","Induction Therapies, LLC",2,2,"","Angelia L. Inscoe","induction-therapies-llc-616487-10312022","The Food and Drug Administration has completed evaluation of your firm\u2019s corrective actions in response to our Warning Letter, CMS# 616487, dated November 23, 2021 for your firm\u2019s Louisville, KY location. Based on our evaluation, it appears that you have addre",0,[],"3014171792","",""],["2022-10-28","Amazon.com, Inc.",0,0,"","Andy Jassy","amazoncom-inc-631751-10282022","This letter concerns your firm\u2019s distribution of \u201cArtri Ajo King Reforzado con Ortiga y Omega 3\u201d (hereinafter \u201cArtri Ajo King\u201d), \u201cArtri King Reforzado con Ortiga y Omega 3,\u201d and \u201cOrtiga Mas Ajo Rey\u201d products that violate the Federal Food, Drug, and Cosmetic Ac",0,[16,17,21],"3016994737","",""],["2022-10-28","Latin Foods Market",0,0,"","Oscar Rios","latin-foods-market-631753-10282022","This letter concerns a product that your firm distributes to consumers via your website, latinfoodsmarket.com. The United States Food and Drug Administration (FDA) has obtained a sample and labeling of the product, \u201cArtri King Reforzado con Ortiga y Omega 3.\u201d",1,[16,17,21],"3021982187","",""],["2022-10-28","Walmart Inc.",0,0,"","Doug McMillon","walmart-inc-631755-10282022","This letter concerns your firm\u2019s distribution of the \u201cArtri King Reforzado con Ortiga y Omega 3\u201d product that violates the Federal Food, Drug, and Cosmetic Act (the \u201cFD&C Act\u201d). As discussed below, your firm is responsible for introducing, delivering, or causi",1,[16,17,21],"3014706754","",""],["2022-10-25","Toxikon Corporation/Labcorp Bedford LLC",1,4,"","Matthew Renninger, DVM, PhD","toxikon-corporationlabcorp-bedford-llc-623581-10252022","The United States Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter CBER-22-001 dated February 10, 2022. Based on our evaluation, it appears that you have addressed the violations",0,[],"1220528","",""],["2022-10-24","Lakpura LLC",0,0,"","Amila Tennakoon","lakpura-llc-643057-10242022","",1,[16,17,19],"3024142962","",""],["2022-10-21","Innova Medical Group, Inc.",2,2,"","Robert \u201cBobby\u201d A. Kasprzak","innova-medical-group-inc-614819-10212022","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (WL #614819) dated June 10, 2021. Based on our evaluation, it appears that you have addressed the violation(s) contained in t",0,[],"3018074194","",""],["2022-10-19","RiteAid Corporation",0,0,"2022-12-27","Kathleen Horton","riteaid-corporation-643207-10192022","The United States Food and Drug Administration (FDA) has reviewed your firm\u2019s drug listing information provided to FDA\u2019s electronic Drug Registration and Listing System (eDRLS) for your drug product, \u201cMucus Relief DM, NDC 11822-7224.\" Our review revealed that",1,[17],"3024210457","",""],["2022-10-17","Unit Dose Services, LLC",0,0,"2022-12-27","Peter Levasseur","unit-dose-services-llc-636177-10172022","",1,[17],"3010164341","",""],["2022-10-14","Valley Biosystems",1,4,"","Steve Cello","valley-biosystems-632553-10142022","The United States Food and Drug Administration (FDA) acknowledges receipt of your letter dated August 24, 2022, responding to the Warning Letter (WL) issued by FDA on August 3, 2022, to Valley Biosystems Inc. (VBS). The WL pertained to the firm\u2019s conduct invol",0,[],"3004554935","",""],["2022-10-07","Namsa",2,4,"","Pinaki Chakraborty, MS, Ph.D., MBA","namsa-544884-10072022","The FDA has completed an evaluation of your firm\u2019s corrective and preventive actions in response to our Warning Letter (WL) dated March 23, 2018, and the follow up inspection conducted on August 30, 2021, to September 21,2021. Based on our evaluation, it appea",0,[9],"3010138955","",""],["2022-10-06","Empowered Diagnostics LLC",2,2,"","Rick J. Hennessey","empowered-diagnostics-llc-638164-10062022","During an inspection of your firm located at 3341 W. McNab Rd., Pompano Beach, Florida on February 3 through February 25, 2022, investigators from the United States Food and Drug Administration (FDA) determined that your firm is a medical device manufacturer a",0,[9,10,12,13,15,17,18,19,20],"3017977164","",""],["2022-10-05","Beijing Xinggu Lvsan Technology Co., Ltd. Formerly known as Beijing Lvsan Technology Co., Ltd.",0,0,"","Mr. Shenxiang Zhai","beijing-xinggu-lvsan-technology-co-ltd-formerly-known-beijing-lvsan-technology-co-ltd-633904","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Beijing Xinggu Lvsan Technology Co., Ltd.(formerly known as Beijing Lvsan Technology Co., Ltd.), FEI 3017227582, at No. 48 Pingwang Street, Xinggu Development Zone Pinggu D",1,[0,3,4,13,14,15,16,17,18],"","",""],["2022-10-05","Eksa Mills S.A. de C.V.",0,0,"","Mr. Esteban Sabugo Rivero","eksa-mills-sa-de-cv-634706-10052022","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Eksa Mills S.A. de C.V., FEI 3016927597, at E. Parque Industrial Carretera Federal Mexico Veracruz 1056, Heroica Puebla De Zaragoza, Puebla, from April 18 to April 19, 2022",1,[3,6,13,14,15,18],"3016927597","",""],["2022-09-30","MicroVention Costa Rica S.R.L.",2,2,"","Charlie Noel","microvention-costa-rica-srl-643188-09302022","During an inspection of your firm located in Alajuela, Costa Rica, on May 23, 2022, through May 26, 2022, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Headway Microcatheter, LVIS, LVIS Jr, Sce",0,[2,4,9,18,20],"3010079067","",""],["2022-09-28","Bespoke Apothecary LLC",0,0,"","April Hart and Bill Krovetcz","bespoke-apothecary-llc-641573-09282022","",1,[16,17,19],"3014847263","",""],["2022-09-27","Lupin Limited",0,0,"","Mr. Akash Patel","lupin-limited-633703-09272022","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Lupin Limited, FEI 3002807512, at T-142, MIDC Tarapur via Boisar, Palghar, from March 22 to April 4, 2022. This warning letter summarizes significant deviations from curren",1,[3,7,14,18],"3002807512","",""],["2022-09-15","Med Pen Concepts, LLC",2,2,"","Amy J. Aarons","med-pen-concepts-llc-632974-09152022","During an inspection of your firm located at 800 W Cummings Park, Woburn, MA 01801 conducted on five dates from April 5, 2022, through April 13, 2022, investigators from the United States Food and Drug Administration (FDA) observed that your firm is a manufact",1,[9,10,12,17,18,20],"3015602723","",""],["2022-09-09","System Kosmetik Produktionsgesellschaft fur kosmetische Gmbh",0,0,"","Ms. Petra Mikschl","system-kosmetik-produktionsgesellschaft-fur-kosmetische-gmbh-632727-09092022","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, System Kosmetik Produktionsgesellschaft fur kosmetische Gmbh, FEI 3011408975, at Raiffeisenstr. 2, Munster, Bavaria, from February 16 to February 18, 2022. This warning let",1,[0,3,4,13,15,18],"3011408975","",""],["2022-08-25","Hanlim Pharm Co., Ltd.",0,0,"","Mr. Daniel SC Park","hanlim-pharm-co-ltd-553021-08252022","The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter 320-19-01 dated October 3, 2018. Based on our evaluation, it appears that you have addressed the violations contained in this",0,[],"3004886113","",""],["2022-08-17","Zhejiang Tianyu Pharmaceutical Co., Ltd.",0,0,"2025-03-11","Mr. Yongjun Tu","zhejiang-tianyu-pharmaceutical-co-ltd-631054-08172022","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Zhejiang Tianyu Pharmaceutical Co., Ltd, FEI 3010972581, at Jiangkou Development Zone, Huangyan Taizhou City, Zhejiang from February 28 to March 4, 2022. This warning lette",1,[3,10,18],"3010972581","",""],["2022-08-16","JAS Diagnostics/Drew Scientific, Inc.",2,2,"","Mr. Jean Felix LaCroix","jas-diagnosticsdrew-scientific-inc-634208-08162022","During an inspection of your firm located at 14100 NW 57th Ct, Miami Lakes, FL 33014-3107 on April 15, 2022 through April 28, 2022, investigators from the United States Food and Drug Administration (FDA) determined that your firm is a medical device manufactur",1,[4,7,10,11,12,18],"3003071743","",""],["2022-08-16","Tramadol US",0,0,"","","tramadol-us-634444-08162022","",1,[16,17,21],"","",""],["2022-08-05","Flawless Beauty and Skin",2,2,"","Jack H. Gindi","flawless-beauty-and-skin-630567-08052022","During an inspection of your firm located at 1750 Brielle Ave, Suites A3, A4, and A6, Ocean, NJ, on November 16, 2021 through January 19, 2022, investigators from the United States Food and Drug Administration (FDA) determined that your firm, under 21 CFR 807.",1,[17,18,20],"3011055149","Seizure","2014-09-04"],["2022-08-04","Amazon.com, Inc.",0,0,"","Andy Jassy","amazoncom-inc-629452-08042022","This letter concerns your firm\u2019s distribution of products that violate the Federal Food, Drug, and Cosmetic Act (the \u201cFD&C Act\u201d). As explained below, the United States Food and Drug Administration (FDA) purchased on your website, www.amazon.com, products inten",0,[16],"3016994737","",""],["2022-08-04","Ariella Naturals",0,0,"","","ariella-naturals-632509-08042022","",0,[16,19],"3022487637","",""],["2022-08-04","FluxxLab LLC",0,0,"","Arend John Kuijvenhoven","fluxxlab-llc-637158-08042022","",0,[16,17,19],"3023213070","",""],["2022-08-04","JB Exchange Inc./Justified Laboratories",0,0,"","Justin Beck","jb-exchange-incjustified-laboratories-631521-08042022","This letter is to advise you that the United States Food and Drug Administration (FDA) has reviewed your website at the Internet address www.justifiedlaboratories.com in August 2022 and has determined that you take orders there for \u201cSkincell Advanced Mole Skin",0,[16,19],"3022320390","",""],["2022-08-03","USA Medical LLC",2,2,"2023-02-09","Damon H. Roberts","usa-medical-llc-631500-08032022","The United States Food and Drug Administration (FDA) conducted an inspection of your firm\u2019s medical device operations at USA Medical LLC (USA Medical), located at 1220 Texan Trail, Suite 205, Grapevine, TX from February 28 through March 15, 2022. During the in",1,[9,10,11,17,18,19,20],"3021504509","",""],["2022-08-03","Valley Biosystems",1,4,"","Granger G. C. Hwa, M.D. Ph.D.","valley-biosystems-632553-08032022","This Warning Letter informs you of objectionable conditions observed during a Food and Drug Administration (FDA) inspection conducted at Valley Biosystems, West Sacramento, California between August 26 and October 8, 2021. FDA investigators met with your staff",0,[9],"3004554935","",""],["2022-07-22","Apollo Health And Beauty Care, Inc.",0,0,"","Mr. Charles Wachsberg","apollo-health-and-beauty-care-inc-593033-07222022","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-20-15 dated December 23, 2019. Based on our evaluation, it appears that you have addressed the violations contained in th",0,[],"3003173295","",""],["2022-07-21","Jose Miguel Gutierrez Salas",0,0,"","Dionisio Martinez","jose-miguel-gutierrez-salas-609983-07212022","The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic rub drug product (also referred to as a consumer hand sanitizer) labeled as MVP Sanitizing Services SPRAY HAND SANITIZER. This drug product was declared to be manufactured a",0,[15,16,17,18,21],"3016833431","",""],["2022-07-20","Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd.",0,0,"","Ms. Zhifang Jiang","guangzhou-orchard-aromatherapy-skin-care-co-ltd-628678-07202022","Your firm is registered with the United States Food and Drug Administration (FDA or Agency) as a manufacturer of over-the-counter (OTC) drug products including hand sanitizers, specifically, Orchard de Flore INSTANT HAND SANITIZER and artnaturals HAND SANITIZE",0,[17,18],"3012368173","",""],["2022-07-14","Daniel Fred Goodman, M.D./Goodman Eye Center",0,0,"","Daniel Fred Goodman, M.D.","daniel-fred-goodman-mdgoodman-eye-center-634247-07142022","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between November 29 and December 13, 2021. Investigator Kristin M. Abaonza, representing FDA, rev",0,[9],"3020460374","",""],["2022-07-13","ACRX Specialty Pharmacy Inc",0,0,"","Eghomware J. Igbinovia","acrx-specialty-pharmacy-inc-609518-07132022","The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our warning letter [case #: 609518; dated July 24, 2020]. Based on our evaluation, it appears that you have adequately addressed the violat",0,[],"3015134033","",""],["2022-07-07","Signa S.A. de C.V.",0,0,"","Mr. Jeff Watson","signa-sa-de-cv-605219-07072022","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-20-40 dated July 14, 2020. Based on our evaluation, it appears that you have addressed the deviations contained in this W",0,[],"3002808161","",""],["2022-07-06","Elite Supplement Center LLC and Elite Training Facility LLC",0,0,"","Mathew Chaffee","elite-supplement-center-llc-and-elite-training-facility-llc-627498-07062022","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.elitesupplementcenter.com/ in June 2022 and has observed that you take orders there for \u201cOstarine MK-2866,\u201d \u201cLigand",1,[16],"3022905376","",""],["2022-07-05","Merete Medical GmbH",2,2,"","Alexia Anapliotis","merete-medical-gmbh-571091-07052022","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS 571091, dated December 31, 2018). Based on our evaluation, it appears that you have addressed the violation(s) contained in th",0,[],"3002949614","",""],["2022-06-30","Bioiberica, SAU",0,0,"2025-01-29","Mr. Luis Solera Blasco","bioiberica-sau-629115-06302022","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Bioiberica, SAU, FEI 1000418405, at Carrer Antic Cami de Tordera 109-119, Palafolls, Barcelona, from January 31 to February 4, 2022. This warning letter summarizes signific",1,[4,6,7,9,18],"1000418405","",""],["2022-06-30","Herbsens Botanicals",0,0,"","","herbsens-botanicals-634373-06302022","This letter is to advise you that the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) reviewed your website at https://herbsenskratom.com/ in May 2022 and June 2022, respectively, and have determined that you take orders there fo",1,[16,19],"3022841615","",""],["2022-06-30","Klarity Kratom",0,0,"","","klarity-kratom-634501-06302022","This letter is to advise you that the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) reviewed your website at https://klaritykratom.com/ on May 31, 2022 and in June 2022, respectively, and have determined that you take orders th",1,[16,19],"3022867869","",""],["2022-06-30","Kratom Exchange",0,0,"","","kratom-exchange-633972-06302022","This letter is to advise you that the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) reviewed your website at https://www.kratomexchange.com/ in May 2022 and June 2022, respectively, and have determined that you take orders ther",1,[16,19],"3022743365","",""],["2022-06-30","MONQ, LLC",0,0,"","","monq-llc-613570-06302022","This letter is to advise you that the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) reviewed your website at https://monq.com/ in May 2022 and June 2022, respectively, and have determined that you take orders there for various",1,[16,19],"3013968294","",""],["2022-06-30","Omni Consumer Products LLC d/b/a YoKratom",0,0,"","","omni-consumer-products-llc-dba-yokratom-634184-06302022","This letter is to advise you that the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) reviewed your website at https://yokratom.com/ in May 2022 and June 2022, respectively, and have determined that you take orders there for all",1,[16,19],"3022770413","",""],["2022-06-27","DDI Multinacional S.A. de C.V.",0,0,"","Ms. Angelica Flores","ddi-multinacional-sa-de-cv-608864-06272022","Your firm registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of consumer antiseptic rub drug products (also referred to as consumer hand sanitizers), labeled as EARTHS AMENITIES Hand Sanitizer and AGAVESPA sk",1,[15,16,17,18,21],"3012510709","",""],["2022-06-27","Noticias Mexico Hoy Grupo Multimedia, S.A. de C.V.",0,0,"","Mr. Francisco Cervantes","noticias-mexico-hoy-grupo-multimedia-sa-de-cv-609658-06272022","Your firm was recently registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a drug product manufactured at your facility: Medical MARY CLEAN HAND Sanitizers, a consumer antiseptic rub (also referred to as co",1,[15,16,17,18,21],"3016821022","",""],["2022-06-22","Industrias Cklass S. de R.L. de C.V.",0,0,"","Mr. Alexis Bellon","industrias-cklass-s-de-rl-de-cv-610275-06222022","Your firm was registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic hand rub drug product (also referred to as consumer hand sanitizer) labeled as cklass Hand Sanitizer WITH ALOE ENRICHE",1,[3,15,16,17,18,21],"3016734550","",""],["2022-06-22","Mirfeel Korea Co., Ltd.",0,0,"","Mr. Moon Su Eun","mirfeel-korea-co-ltd-627401-06222022","Your facility is registered with the U.S. Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products, including consumer antiseptic hand rub drug products (also referred to as consumer hand sanitizers). FDA conducted testing o",1,[6,13,15,17,18],"3016921925","",""],["2022-06-13","Glicerinas Industriales, S.A. de C.V.",0,0,"","Mr. Alfredo Moran Sanchez","glicerinas-industriales-sa-de-cv-633340-06132022","The U.S. Food and Drug Administration (FDA) notified your site, Glicerinas Industriales, S.A. de C.V. (\u201cGLINSA\u201d), FEI 3016420687, at Calle Uranio No. 80, Col. Arenales Tapatios, Zapopan, of a planned inspection of your drug manufacturing facility from May 16 t",1,[18],"3016420687","",""],["2022-06-03","Grimann S.A. de C.V.",0,0,"","Esther Gonzalez","grimann-sa-de-cv-632272-06032022","The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #2257. Based on our evaluation, it appears that you have included a marketing end date of May 23, 2022, indicating that the product",0,[],"3006076347","",""],["2022-05-27","Smitha C. Reddy, M.D./ACRC Studies, LLC",0,0,"","Smitha C. Reddy, M.D.","smitha-c-reddy-mdacrc-studies-llc-634702-05272022","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between August 4 and August 20, 2021. Investigator Theressa B. Smith, representing FDA, reviewed",1,[9],"3017760842","",""],["2022-05-23","Grimann S.A. de C.V.",0,0,"2022-06-24","Esther Gonzalez","grimann-sa-de-cv-632272-05232022","The United States Food and Drug Administration (FDA) has reviewed your firm\u2019s drug listing information provided to FDA\u2019s electronic Drug Registration and Listing System (eDRLS) for your drug product, Derofen Miel, NDC 81660-435. Our review determined that your",1,[17,21],"3006076347","",""],["2022-05-23","Wickimed Medical Equipment Manufacturing Co., Ltd.",2,2,"","Mr. Mac Lai","wickimed-medical-equipment-manufacturing-co-ltd-623042-05232022","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter CMS # 623042, dated January 7, 2022. Based on our evaluation, it appears that you have addressed the violation(s) contained in this",0,[],"3010601992","",""],["2022-05-19","Ayuryoga, Inc.",0,0,"","Nikhil Gupta","ayuryoga-inc-628168-05192022","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.kottakkalusa.com/, which redirects to https://www.kottakkal.shop/, in March 2022 and has observed that you take orders there",1,[16,19],"3007204580","",""],["2022-05-19","Santhigram Kerala Ayurvedic Co. of U.S., Inc.",0,0,"","Gopinathan Nair","santhigram-kerala-ayurvedic-co-us-inc-625892-05192022","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address http://www.santhigram.us in March 2022 and has observed that you take orders there for various ayurvedic products, including but not lim",1,[16,19],"3014227710","",""],["2022-05-04","ATLRx, Inc.",0,11,"","Chase Slappey","atlrx-inc-618341-05042022","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.atlrx.com in February 2022 and has determined that you take orders there for various human and animal products, which you represent",0,[11,16,17,18,19,20,21],"3020449945","",""],["2022-05-04","BioMD Plus LLC",0,11,"","Jonathan M. Levitt","biomd-plus-llc-618460-05042022","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.biomdplus.com in February 2022 and has determined that you take orders there for various human and animal products, which you represent as containing can",1,[11,16,17,18,19,20,21],"3020496299","",""],["2022-05-04","Delta 8 Hemp",0,9,"","","delta-8-hemp-618368-05042022","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://delta8thc.market/ in April 2022 and has determined that you take orders there for various human products, which you represent as",1,[3,11,16,17,18,19,20,21],"3020462698","",""],["2022-05-04","Inhousepharmacy.vu",0,0,"","","inhousepharmacyvu-620327-05042022","",1,[16],"","",""],["2022-05-04","Kingdom Harvest",0,11,"","Shelle Rogers","kingdom-harvest-625058-05042022","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.kingdomharvest.com from October 2021 through April 2022 and has determined that you take orders there for various human and animal p",0,[3,11,16,17,18,19,21],"3018097746","",""],["2022-05-04","M Six Labs, Inc.",0,11,"","Terry Maxwell","m-six-labs-inc-618701-05042022","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://m6labs.com in February 2022 and has determined that you take orders there for various human and animal products, which you represent as containing ca",0,[11,16,17,18,19,20,21],"3020522574","",""],["2022-05-02","David Cosmetic Co., Ltd.",0,0,"","Mr. Kang Wook Lee","david-cosmetic-co-ltd-627408-05022022","Your firm is registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic hand rub drug product (also referred to as a consumer hand sanitizer), labeled as CALA Advanced Hand Sanitizer Moisturi",1,[15,18],"3015781135","",""],["2022-04-19","Guangzhou Zhongkebaishi Health Industry Co., Ltd.",0,0,"","Mr. Shaoshan Chen","guangzhou-zhongkebaishi-health-industry-co-ltd-613267-04192022","Your firm was registered as a human drug manufacturer. The United States Food and Drug Administration (FDA) conducted testing of a consumer antiseptic hand rub drug product (also referred to as a consumer hand sanitizer), labeled as Hand Sanitizer Gel. This dr",1,[5,15,16,17,18,21],"3016706196","",""],["2022-04-19","Kleenhanz, LLC",0,0,"","Mr. Lance FitzSimon","kleenhanz-llc-605499-04192022","",1,[16,17],"3012895507","",""],["2022-04-13","AMBI Enterprises LLC",0,0,"","David Lennarz","ambi-enterprises-llc-628367-04132022","This letter concerns your firm\u2019s distribution of drug products to bleach and/or lighten the skin. AMBI\u00ae SKINCARE Fade Cream OILY SKIN and AMBI\u00ae SKINCARE Fade Cream NORMAL SKIN drug products are unapproved new drugs introduced or delivered for introduction into",1,[16,17],"3021386591","",""],["2022-04-13","Clinical Formula LLC",0,0,"","Ken Kutanakit","clinical-formula-llc-628372-04132022","This letter concerns your firm\u2019s manufacturing of a drug product to bleach and/or lighten the skin. Clinical Formula\u2122 Bleaching Lotion drug product is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of sect",1,[16,17],"2023611","",""],["2022-04-13","Dr. Thomas Balshi/Intilight",0,0,"","","dr-thomas-balshiintilight-628402-04132022","",1,[16,17],"3021618493","",""],["2022-04-13","Genomma Lab USA, Inc.",0,0,"","Bradley Johnson","genomma-lab-usa-inc-628381-04132022","",1,[16,17],"3008062835","",""],["2022-04-13","M & M Beauty and Wellness, LLC",0,0,"","Michelle Messer","m-m-beauty-and-wellness-llc-628392-04132022","",1,[16,17],"3021418490","",""],["2022-04-13","Neoteric Cosmetics, Incorporated/Scott\u2019s Liquid Gold, Inc.",0,0,"","Tisha Pedrazzini","neoteric-cosmetics-incorporatedscotts-liquid-gold-inc-628399-04132022","",1,[16,17],"1000149923","",""],["2022-04-13","Skin Authority, L.L.C.",0,0,"","Ted Hilling","skin-authority-llc-628385-04132022","",1,[16,17],"3009687949","",""],["2022-04-13","Skin PS Brands",0,0,"","Lindsey Lisse","skin-ps-brands-628396-04132022","",1,[16,17],"3021386595","",""],["2022-04-13","SkinPro",0,0,"","Tim Schmidt","skinpro-628398-04132022","",1,[16,17],"3021071752","",""],["2022-04-13","True Earth Health Products, LLC",0,0,"","Jonathan Greenhut","true-earth-health-products-llc-628383-04132022","",1,[16,17],"3015200875","",""],["2022-04-13","Ultimark Products",0,0,"","David Zuckerberg","ultimark-products-628389-04132022","",1,[16,17],"3021385926","",""],["2022-04-06","Sensory Cloud, Inc",0,0,"","David Edwards","sensory-cloud-inc-628897-04062022","",1,[16,17,19],"3021477338","",""],["2022-04-06","www.wellerectile.com",0,0,"","","wwwwellerectilecom-615690-04062022","",1,[16,17,21],"","",""],["2022-04-05","CofixRx, LLC",0,0,"","Dennis Kaiser","cofixrx-llc-626860-04052022","",1,[16,17],"3021350094","",""],["2022-04-05","\"Daniel C. Tarquinio, D.O./Center for Rare Neurological Diseases",0,0,"","","daniel-c-tarquinio-docenter-rare-neurological-diseases-630976-04052022","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between October 18 and November 5, 2021. Investigator Sereen G. Morgan-Murray, representing FDA,",1,[9],"3019794456","",""],["2022-04-04","Fujifilm Corporation",2,2,"","Henry Izawa","fujifilm-corporation-546987-04042022","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 546987, dated March 9, 2018). Based on our evaluation, it appears that you have addressed the violation(s) contained in this",0,[],"3001722928","",""],["2022-04-04","Olympus Medical Systems Corporation",2,2,"","Julien Sauvagnargues","olympus-medical-systems-corporation-546986-04042022","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 546986, dated March 9, 2018). Based on our evaluation, it appears that you have addressed the violation(s) contained in this",0,[],"3002807795","",""],["2022-03-30","kubapharm.com",0,0,"","","kubapharmcom-622051-03302022","",1,[17],"","",""],["2022-03-30","premiumlightsupplier.com",0,0,"","","premiumlightsuppliercom-622056-03302022","",1,[17],"","",""],["2022-03-28","CBD Social",0,0,"","","cbd-social-627044-03282022","",1,[16,17,19],"3021632117","",""],["2022-03-28","Cureganics",0,0,"","","cureganics-627288-03282022","",1,[16,17,19],"3021644020","",""],["2022-03-28","Functional Remedies, LLC D/B/A Synchronicity Hemp Oil",0,0,"","Andrew Campbell","functional-remedies-llc-dba-synchronicity-hemp-oil-627208-03282022","",1,[16,17,19],"3013917986","",""],["2022-03-28","Greenway Herbal Products LLC",0,0,"","David B. Laroche","greenway-herbal-products-llc-627042-03282022","",1,[16,17,19],"3021632769","",""],["2022-03-28","Heaven\u2019s Organic LLC",0,0,"","Angela Sidders and David Sidders","heavens-organic-llc-627359-03282022","",1,[16,17,19],"3021646825","",""],["2022-03-28","Nature's Highway",0,0,"","","natures-highway-627304-03282022","",1,[16,17,19],"3021656045","",""],["2022-03-28","UPSY LLC",0,0,"","Alex Guarino","upsy-llc-627962-03282022","",1,[16,17,19],"3021736332","",""],["2022-03-25","Iodine Products Inc",0,0,"","Gene Rosov","iodine-products-inc-628296-03252022","",1,[16,17,19],"3012356277","",""],["2022-03-24","Applied Biological Laboratories Inc.",0,0,"","Mr. Michael Latefi","applied-biological-laboratories-inc-627062-03242022","",1,[16,17],"3013176939","",""],["2022-03-16","ECI Pharmaceuticals, LLC",0,0,"","John Copanos","eci-pharmaceuticals-llc-625254-03162022","",0,[],"3008798439","",""],["2022-03-15","Iotech International, LLC",0,0,"","Herb Moskowitz, DDS","iotech-international-llc-617715-03152022","",1,[16,17],"3016927600","",""],["2022-03-14","Dr Retter Ec Wladyslaw Retter",0,0,"","Dr. Wladyslaw Retter","dr-retter-ec-wladyslaw-retter-619881-03142022","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our June 2, 2021, request for records and other informati",1,[4,13,15,18],"3014686302","",""],["2022-03-10","Soda Pharm",0,0,"","Dawn Combs","soda-pharm-626261-03102022","",1,[16,17,19],"3018016482","",""],["2022-03-07","Viraldine, LLC",0,0,"","","viraldine-llc-625675-03072022","",1,[16,17],"3021171359","",""],["2022-02-28","NeuroField, Inc.",2,2,"","Nicholas J. Dogris","neurofield-inc-621767-02282022","The United States Food and Drug Administration (FDA) conducted an inspection of your medical device operations located at 386 W. Line Street, Bishop, CA from September 28 through October 6, 2021. During the inspection, an FDA Investigator determined that your",1,[9,10,13,17,18,20],"3010900508","",""],["2022-02-28","Sabine S. Hazan, M.D.",0,0,"","Sabine S. Hazan, M.D.","sabine-s-hazan-md-628110-02282022","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between September 13 and September 21, 2021. Investigators Andrace Deyampert and Linda Galindo, r",1,[],"3016661283","",""],["2022-02-25","Ivermectin24h.com",0,0,"","","ivermectin24hcom-615637-02252022","",1,[17],"","",""],["2022-02-22","My Natural Treatment",0,0,"","Andreea Laza","my-natural-treatment-624734-02222022","",1,[16,17,19],"3021368926","",""],["2022-02-17","Invisi Smart Technologies UK LTD",2,2,"","Ms. Saba Yussouf","invisi-smart-technologies-uk-ltd-614512-02172022","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter CMS #614512 dated August 24, 2021. Based on our evaluation, it appears that you have addressed the violation(s) contained in this W",0,[],"3017168126","",""],["2022-02-17","Lusys Laboratories, Inc.",2,2,"","Mr. James Lu","lusys-laboratories-inc-625807-02172022","",1,[17,18,19,20],"3004473533","",""],["2022-02-15","Extrapharmacy.ru",0,0,"","Mikhail Kazankov","extrapharmacyru-615132-02152022","",1,[16,17,21],"","",""],["2022-02-15","rxshopmd.com",0,0,"","","rxshopmdcom-615753-02152022","",1,[16,17,21],"","",""],["2022-02-11","CardioQuip, LLC",2,2,"","Douglas E. Platt","cardioquip-llc-621738-02112022","",1,[3,4,9,10,11,12,17,18,20],"3007899424","",""],["2022-02-10","Toxikon Corporation/Labcorp Bedford LLC",1,4,"2022-11-02","Laxman S. Desai, D.Sc.","toxikon-corporationlabcorp-bedford-llc-623581-02102022","This Warning Letter informs you of objectionable conditions observed during a Food and Drug Administration (FDA) inspection conducted between August 13 and September 14, 2021. An FDA investigator met with you during the inspection to review your conduct of a n",1,[],"1220528","",""],["2022-02-04","Crystal Clear Supplements",0,0,"","Gordon Cady","crystal-clear-supplements-620285-02042022","This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.crystalclearsupplements.com/ in December 2021 and has observed that you take orders for numerous products, includin",1,[11,16,19],"3019922558","",""],["2022-02-04","Richard J. Obiso, PhD dba Avila Herbals, LLC",0,0,"","Richard J. Obiso, Ph.D.","richard-j-obiso-phd-dba-avila-herbals-llc-622821-02042022","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site from July 12 to July 26, 2021. Investigator Melanie N. Daniels, representing FDA, reviewed the ro",1,[],"3016760965","",""],["2022-02-03","ECI Pharmaceuticals, LLC",0,0,"","John S. Copanos","eci-pharmaceuticals-llc-625254-02032022","The United States Food and Drug Administration (FDA) has reviewed your firm\u2019s drug listing information provided to FDA\u2019s electronic Drug Registration and Listing System (eDRLS) for your drug products, \u201cesterified estrogens and methyltestosterone\u201d (NDC 51293-63",1,[17],"3008798439","",""],["2022-02-03","ECI Pharmaceuticals, LLC",0,0,"","John S. Copanos","eci-pharmaceuticals-llc-625254-02032022-0","The United States Food and Drug Administration (FDA) has reviewed your firm\u2019s drug listing information provided to FDA\u2019s electronic Drug Registration and Listing System (eDRLS) for your drug products, \u201cesterified estrogens and methyltestosterone\u201d (NDC 51293-63",1,[17],"","",""],["2022-02-03","Pharmacy2Home/LandiCom Holding LTD",0,0,"","","pharmacy2homelandicom-holding-ltd-615137-02032022","",1,[16,17,21],"","",""],["2022-02-02","Indiana Chem-Port",0,0,"","Mr. Hitendra Desai","indiana-chem-port-618173-02022022","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Indiana Chem-Port, FEI 3005564386, at 349 GIDC Industrial Estate, Makarpura, Vadodara, Gujarat, India, from August 2 to 7, 2021. This warning letter summarizes significant",1,[0,3,4,6,14,15,17,18],"3005564386","",""],["2022-02-01","New Earth Healing Essentials, LLC d/b/a 5D Full Disclosure",0,8,"","Lauryn Suarez and Ashley Peluso","new-earth-healing-essentials-llc-dba-5d-full-disclosure-620001-02012022","This letter is to advise you that the United States Food and Drug Administration (FDA) has reviewed your website at https://www.5dfulldisclosure.org/, which redirects to https://newearthhealingessentials.ecwid.com/, from November through December 2021, and has",1,[16,18,19],"3016601959","",""],["2022-01-28","Skin Sheek",2,2,"2023-03-14","Meredith Dodini Hult","skin-sheek-612682-01282022","The United States Food and Drug Administration (FDA) has learned that your firm is marketing the CLEAR, ERASE, LIFT, and SILK in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act). Unde",1,[17,18,20],"3016035303","",""],["2022-01-18","CES LLC",0,0,"","Eddie Voloshin","ces-llc-623495-01182022","This letter concerns your firm\u2019s distribution of Hand Sanitizer as an alcohol-based over-the-counter (OTC) hand sanitizer. Specifically, your Hand Sanitizer is packaged in 8.45 ounce bottles resemble beverage containers customarily purchased by U.S. consumers.",1,[16,17],"3019848311","",""],["2022-01-12","Aurobindo Pharmaceutical Limited",0,0,"2025-11-17","Mr. Narayanan Govindarajan","aurobindo-pharmaceutical-limited-618091-01122022","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Aurobindo Pharmaceutical Limited Unit I, FEI 3004021253, at Survey 379, 385, 386, 388 \u2013 396, Borpatla Village, Doultabad, Telangana, 502296 India, from August 2 to 12, 2021",1,[7,14,18],"3004021253","",""],["2022-01-07","Wickimed Medical Equipment Manufacturing Co., Ltd.",2,2,"2022-06-02","Mac Lai","wickimed-medical-equipment-manufacturing-co-ltd-623042-01072022","During an inspection of your firm located in HuiZhou China, on September 6, 2021 through September 14, 2021, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Class II Sterile Single Use Dispos",1,[2,10,11,12,15,17,18,20],"3010601992","",""],["2022-01-06","Cosmo Bio Co., Ltd.",0,0,"","Mr. Kum Yun-Hyun","cosmo-bio-co-ltd-611552-01062022","While your facility was registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products, FDA reviewed the records you submitted in response to our April 22, 2020, request for records and other info",1,[3,6,9,16,17,18,21],"3015297228","",""],["2022-01-06","Unimicro Medical Systems-Shenzhen Co., Ltd.",2,2,"2023-05-31","Roly Lee","unimicro-medical-systems-shenzhen-co-ltd-624560-01062022","During an inspection of your firm located in Shenzhen, China, on September 15, 2021, through September 26, 2021, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Veress Pneumoperitoneum Needles. U",1,[2,4,9,10,11,12,18,20],"3010806467","",""],["2022-01-03","Amcyte Pharma, Inc.",0,0,"","Gustavo Mahler","amcyte-pharma-inc-623474-01032022","",0,[16,17,19],"3018703165","",""],["2021-12-29","Genesis Partnership Company SA",0,0,"","Elmar Giovanni Cardona Quintana","genesis-partnership-company-sa-618953-12292021","This letter concerns your firm\u2019s marketing of Bathletix HAND SANITIZER, bearing the trademarked logo of the Baltimore Orioles or other team logos of Major League Baseball and the National Basketball Association, as an alcohol based over-the-counter (OTC) hand",1,[16,17],"3016785739","",""],["2021-12-29","Varigard, LLC",0,0,"","Mike Paolillo","varigard-llc-616757-12292021","",0,[16,17],"3017449974","",""],["2021-12-21","Vasyl Melnyk, M.D.",0,0,"","","vasyl-melnyk-md-623671-12212021","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site from September 13 to September 14, 2021. Investigator Tawny L. Colling, representing FDA, reviewe",0,[],"3019329346","",""],["2021-12-15","Maquiladora Miniara SA de CV",0,0,"","Mr. Anuar Farah Said","maquiladora-miniara-sa-de-cv-609152-12152021","Your firm was recently registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic rub drug product (also referred to as a consumer hand sanitizer) labeled as Shine and clean Hand Sanitizer Ge",1,[15,16,17,18,21],"3011856577","",""],["2021-12-14","Guangdong Kemei Pharmaceutical Technology Co. Ltd.",0,0,"","Mr. Jack Chen","guangdong-kemei-pharmaceutical-technology-co-ltd-612090-12142021","Your firm is registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic hand rub drug product (also referred to as a consumer hand sanitizer), labeled as IMC WASH-FREE HAND SANITIZER. This dr",1,[15,16,17,18,21],"3017086967","",""],["2021-12-09","Medtronic, Inc.",2,2,"2023-04-28","Geoff S. Martha","medtronic-inc-617539-12092021","During an inspection of your firm located in Northridge, California, on June 7, 2021 through July 7, 2021, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the MiniMed 600 series insulin infusion",1,[9,18],"3003166194","",""],["2021-12-07","Guangzhou Shiruoni Cosmetics Co., Ltd",0,0,"","Ms. Ice Huang","guangzhou-shiruoni-cosmetics-co-ltd-613170-12072021","Your firm registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic rub drug product (also referred to as a consumer hand sanitizer), labeled as IMPACTA HEALTH HAND SANITIZER. This drug prod",1,[15,17,18],"3014510437","",""],["2021-12-01","DermaCare Biosciences, LTD.",2,2,"","Rich Butler","dermacare-biosciences-ltd-617910-12012021","",1,[17,18,19,20],"3017529301","",""],["2021-12-01","Eagle Energy USA, Inc.",0,0,"","","eagle-energy-usa-inc-617712-12012021","This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://eagle.energy in September 2021 and has determined that you take orders there for \u201cCaffeine Pen\u201d products packaged as \u201cLychee Ice\u201d and \u201c",1,[16,19],"3013771851","",""],["2021-12-01","NV Nutrition, LLC",0,0,"","Josh Matzkin","nv-nutrition-llc-617979-12012021","This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at the Internet addresses www.nutrovape.com and https://nutriair.com/ in October 2021 and has determined that you take orders there for numerous \u201cvaporizer\u201d products,",1,[16,19],"3007254599","",""],["2021-12-01","VitaCig, Inc.",0,0,"","Paul Rosenberg","vitacig-inc-617847-12012021","This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.vitaciggroup.com in September 2021 and has determined that you take orders there for your \u201cVitaCig products,\u201d which include a varie",1,[16,19],"3020306650","",""],["2021-12-01","Vitamin Vape, Inc.",0,0,"","George Michalopoulos","vitamin-vape-inc-617787-12012021","This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.vitaminvape.co in September 2021 and has determined that you take orders there for the \u201cB 12 VITAMINVAPE\u201d product. We have also rev",1,[16,19],"3014219499","",""],["2021-12-01","VitaStik, Inc.",0,0,"","Alfred Santos","vitastik-inc-617713-12012021","This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.vitastik.com in September 2021 and has determined that you take orders there for a variety of oral inhalation products under the \u201cVitaStik\u201d",1,[16,19],"3012856522","",""],["2021-11-24","DSAART, LLC. dba Alpha Aesthetics",2,2,"","Douglas Steinbrech","dsaart-llc-dba-alpha-aesthetics-618157-11242021","The United States Food and Drug Administration (FDA) conducted an inspection of your medical device operations at 2950 Arrowhead Dr., Carson City, NV 89706 from July 19, 2021 through August 5, 2021. During the inspection, an FDA Investigator determined that yo",1,[2,4,9,10,11,12,17,18,20],"3003897287","",""],["2021-11-23","Hubei Kangzheng Pharmaceutical Co., Ltd.",0,0,"","Mr. Chen Tianzhong","hubei-kangzheng-pharmaceutical-co-ltd-616581-11232021","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Hubei Kangzheng Pharmaceutical Co., Ltd., FEI 3010580682, located at No. 88 Hexi Jinquan Road, Anlu City, Hubei Province, China, from June 16 to 24, 2021. This warning lett",1,[1,2,3,4,6,7,8,16,17,18],"3010580682","",""],["2021-11-23","Induction Therapies, LLC",2,2,"2022-11-08","Angelia L. Inscoe","induction-therapies-llc-616487-11232021","The United States Food and Drug Administration (FDA) conducted an inspection of your firm\u2019s medical device operations at 3600 Chamberlain Lane, Suite 336, Louisville, KY, from June 15 \u2013 June 29, 2021. During the inspection, an FDA investigator from the United",1,[17,18,20],"3014171792","",""],["2021-11-18","Invacare Corporation",2,2,"2023-08-24","Matthew E. Monaghan","invacare-corporation-617319-11182021","The United States Food and Drug Administration (FDA) conducted an inspection of your firm\u2019s medical device operations at 1200 Taylor Street (FEI: 1525712), One Invacare Way (FEI: 3002889431), and 39400 Taylor Parkway (FEI: 1000220413), from May 25, 2021 to Jun",1,[9,10,18,20],"1000220413","",""],["2021-11-16","Global Medical Production Co Ltd",2,2,"","Jeff Dai General","global-medical-production-co-ltd-620544-11162021","During an inspection of your firm located in Jiaxing, China on July 15, 2021 through July 30, 2021, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Sterile and Non-Sterile Electrosurgical Scissor",0,[2,4,9,10,11,12,17,18,20],"3006897899","",""],["2021-11-16","Yuki Gosei Kogyo Co., Ltd.",0,0,"","Mr. Makoto Kito, Ph.D.","yuki-gosei-kogyo-co-ltd-547871-11162021","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-18-63 dated July 17, 2018. Based on our evaluation, it appears that you have addressed the deviations contained in this W",0,[],"3002808534","",""],["2021-11-04","21st Century Scientific Inc",2,2,"","Ronald D. Davidson","21st-century-scientific-inc-566834-11042021","The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated May 13, 2019. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future",0,[],"1000125727","",""],["2021-11-04","Bionateo Sp. z.o.o.",0,0,"","Mr. Dominik Wojciechowski","bionateo-sp-zoo-614651-11042021","Your firm is recently registered as a human drug manufacturer. The United States Food and Drug Administration (FDA) conducted testing of a consumer antiseptic hand rub drug product (also referred to as a consumer hand sanitizer), labeled as ALTAIO HAND SANITIZ",1,[15,16,17,18,21],"3017231855","",""],["2021-11-04","Zhejiang Huahai Pharmaceutical",0,0,"","Mr. Baohua Chen","zhejiang-huahai-pharmaceutical-566685-11042021","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-19-04 dated November 29, 2018. Based on our evaluation, it appears that you have addressed the deviations contained in th",0,[],"3003885745","",""],["2021-10-27","Battelle Memorial Institute",2,2,"","Jeff Rose","battelle-memorial-institute-610928-10272021","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 610928, dated October 7, 2020). Based on our review of your responses, you have addressed the violations contained in this W",0,[],"1523658","",""],["2021-10-22","DongBang Cosmetics Co., Ltd.",0,0,"","Mr. Kwon Moon Oh","dongbang-cosmetics-co-ltd-610364-10222021","Your firm is registered as a human drug manufacturer. The United States Food and Drug Administration (FDA) conducted testing of a consumer antiseptic hand rub drug product (also referred to as a consumer hand sanitizer), labeled as MISSY KAY Premium Hand Sanit",1,[1,2,5,15,16,17,18,21],"3013677509","",""],["2021-10-14","Davati Medical Supply LLC",1,4,"","Philip Quick","davati-medical-supply-llc-615530-10142021","The United States Food and Drug Administration (FDA) has completed evaluation of your firm\u2019s corrective actions in response to the Warning Letter (#CBER 21-02) issued by FDA to Davati Medical Supply, LLC on June 26, 2021. Based on our evaluation, it appears th",0,[],"3019569787","",""],["2021-10-14","Joseph A. Zadra, M.D.",0,0,"","","joseph-zadra-md-619451-10142021","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between May 3 and May 7, 2021. Investigator Craig A. Garmendia, representing FDA, reviewed your c",1,[],"3018061341","",""],["2021-10-14","New Green Nutrition, Inc.",0,9,"","Xiang Lu Peng","new-green-nutrition-inc-615846-10142021","This letter is to advise you that the United States Food and Drug Administration (FDA) has reviewed your website at www.newgreenusa.com in August 2021 and has determined that you take orders there for \u201cXiao Ke Wan\u201d (aka \u201cXiaoKe Pills\u201d), \u201cDiabetee-Care,\u201d and \u201cS",1,[16,17,19,21],"3012788298","",""],["2021-10-13","Takeda Pharmaceutical Company Limited",0,0,"","Mr. Christophe Weber","takeda-pharmaceutical-company-limited-603596-10132021","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter 320-20-37 dated June 9, 2020. Based on our evaluation, it appears that you have addressed the violations contained in this Wa",0,[],"3004664162","",""],["2021-10-08","AriBio H&B Co., Ltd.",0,0,"","Ms. Jung Ok Lee","aribio-hb-co-ltd-613107-10082021","Your firm was registered as a human drug manufacturer. The United States Food and Drug Administration (FDA) conducted testing of a consumer antiseptic rub drug product (also referred to as a consumer hand sanitizer), labeled as Hand Sanitizer Original. This dr",1,[15,17,18],"3009836687","",""],["2021-10-07","Notarika, S.A. de C.V.",0,0,"","Ms. Susana Elizabeth Garcia Ballesteros","notarika-sa-de-cv-609174-10072021","Your firm was recently registered as a human drug manufacturer. The United States Food and Drug Administration (FDA) conducted testing of a consumer antiseptic hand rub (also referred to as a consumer hand sanitizer) labeled as Greenfrog HAND SANITIZER. This d",1,[15,16,17,18,21],"3016931302","",""],["2021-10-05","Owlet Baby Care, Inc.",2,2,"2024-06-28","Mr. Kurt Workman","owlet-baby-care-inc-616354-10052021","This is an amendment to the letter dated October 1, 2021. The United States Food and Drug Administration (FDA) has learned that your firm is marketing Owlet Smart Socks in the United States without marketing clearance or approval, in violation of the Federal F",1,[17,18,20],"3012977166","",""],["2021-10-01","Smiths Medical ASD Inc.",2,2,"","JehanZeb Noor","smiths-medical-asd-inc-617147-10012021","The United States Food and Drug Administration (FDA) conducted an inspection of your firm\u2019s medical device operations at Smiths Medical ASD, Inc., located at 6000 Nathan Lane N. Minneapolis, Minnesota, from February 23 \u2013 March 30, 2021 with an amended 483 sign",1,[9,10,11,12,17,18,20],"3012307300","",""],["2021-09-30","GuangZhou YouXing Cosmetic Co., Ltd",0,0,"","Mr. Lijuan Zhen","guangzhou-youxing-cosmetic-co-ltd-610709-09302021","Your firm is registered as a human drug manufacturer. The United States Food and Drug Administration (FDA) conducted testing of a consumer antiseptic hand rub drug product (also referred to as a consumer hand sanitizer), labeled as V&W ADVANCE HAND SANITIZER R",1,[15,16,17,18],"3011347036","",""],["2021-09-30","Limpo Quimicos, SA de CV",0,0,"","Mr. Santiago Alvarado","limpo-quimicos-sa-de-cv-608859-09302021","Your firm was registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of consumer antiseptic hand rub drug products (also referred to as consumer hand sanitizers), labeled as Andy\u2019s Best ADVANCED HAND SANITIZER (6",1,[15,16,17,18,21],"3016628153","",""],["2021-09-30","RAAS Nutritionals, LLC/Rare Antibody Antigen Supply, Inc.",0,0,"","Kieu Hoang","raas-nutritionals-llcrare-antibody-antigen-supply-inc-616560-09302021","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted from March 15 to 23, 2021. Investigator Stuart W. Russell, representing FDA, reviewed the role of RAAS Nutritionals, LL",1,[],"3015451503","",""],["2021-09-29","HealthMEDS Inc.",0,0,"","","healthmeds-inc-618484-09292021","Your firm is registered with the United States Food and Drug Administration (FDA or Agency) as a manufacturer of over-the-counter (OTC) drug products; specifically, products listed include ProClean-Pure Atomizer Mist 5 mL. On February 1, 2021, the FDA sent an",1,[],"3016884869","",""],["2021-09-29","Healthy Foods & Nutrition Lab de Mexico S.A. de C.V.",0,0,"","Mr. Juan Pablo Maza Gomez","healthy-foods-nutrition-lab-de-mexico-sa-de-cv-609608-09292021","Your firm was registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic hand rub drug product (also referred to as a consumer hand sanitizer), labeled as HF & NLab VERIO HEALTHCARE ALCOHOL A",1,[4,14,15,16,17,18],"3015851305","",""],["2021-09-29","True Chemical Solutions, LLC",0,0,"","Mr. Travis Pitcock","true-chemical-solutions-llc-616672-09292021","Your firm is registered with the United States Food and Drug Administration (FDA or Agency) as a manufacturer of over-the-counter (OTC) drug products; specifically, products listed include HAPPY HANDS Hand Sanitizer Topical Gel with Moisturizing Solution. On N",1,[],"3016866715","",""],["2021-09-28","Strategia Project Management, Inc.",0,0,"","Chris Mashburn","strategia-project-management-inc-615307-09282021","",1,[16,17,19],"3017262425","",""],["2021-09-27","Captain\u2019s Cloth",2,2,"","Brian Eckert","captains-cloth-613965-09272021","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 613965, July 2, 2021). Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warnin",0,[],"3018238789","",""],["2021-09-27","Databazaar.com",2,2,"","","databazaarcom-617199-09272021","",0,[],"3020048549","",""],["2021-09-27","Dongguan City Xinyuan Nonwoven Co., Ltd.",2,2,"","Mr. Jack Cheng","dongguan-city-xinyuan-nonwoven-co-ltd-612354-09272021","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 612354, May 27, 2021). Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warnin",0,[],"3016670391","",""],["2021-09-27","Fixture Display LLC",2,2,"","Mr. Alan Gao","fixture-display-llc-615052-09272021","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 615052, June 28, 2021). Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warni",0,[],"3013288285","",""],["2021-09-27","Irvin, Inc.",2,2,"","Denise Cannon","irvin-inc-612738-09272021","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 612738, May 27, 2021). Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warnin",0,[],"3017763395","",""],["2021-09-27","Manhattan Stitching Company, Inc.",2,2,"","Mr. Cory Jachnuk","manhattan-stitching-company-inc-611719-09272021","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 611719, August 13, 2021). Based on our evaluation, it appears that you have addressed the violation(s) contained in this War",0,[],"3015113525","",""],["2021-09-27","Mask Supply Store",2,2,"","","mask-supply-store-612585-09272021","",0,[],"3017848077","",""],["2021-09-27","Nature\u2019s Distributing; Club Clean Inc/BuyMedicalMasksNow.com",2,2,"","Mr. Edward Mauro","natures-distributing-club-clean-incbuymedicalmasksnowcom-613952-09272021","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 613952, May 28, 2021). Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warnin",0,[],"3016711464","",""],["2021-09-27","Professional World Store",2,2,"","","professional-world-store-612406-09272021","",0,[],"3017761921","",""],["2021-09-27","Shenzhen Weifa Technology Co., Ltd",2,2,"","Huaquan Yu","shenzhen-weifa-technology-co-ltd-609828-09272021","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 609828, March 11, 2021). Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warn",0,[],"3016648101","",""],["2021-09-27","World Packaging Solutions, LLC",2,2,"","Jim Sonsalla","world-packaging-solutions-llc-612824-09272021","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 612824, June 28, 2021). Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warni",0,[],"3017029256","",""],["2021-09-22","Ardil Comercial S.R.L.",0,0,"","Ms. Cecilia Ramirez","ardil-comercial-srl-612018-09222021","Your firm registered as a human drug manufacturer. The United States Food and Drug Administration (FDA) conducted testing of a consumer antiseptic hand rub drug product (also referred to as a consumer hand sanitizer), labeled as Alcohol Isopropilico Hand Sanit",1,[15,16,17,18],"3012644697","",""],["2021-09-15","Laboratorio Pharma International SRL",0,0,"","Aurelio Nembrini","laboratorio-pharma-international-srl-614766-09152021","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our November 6, 2020, request for records and other infor",1,[3,6,8,13,16,17,18],"3012015184","",""],["2021-09-15","Nanomateriales Qu\u00edmicos Avanzados, S.A. de C.V.",0,0,"","Mr. Joel Guti\u00e9rrez Antonio","nanomateriales-quimicos-avanzados-sa-de-cv-609969-09152021","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products, including consumer antiseptic rub drug products (also referred to as a consumer hand sanitizer). The FDA conducted",1,[6,13,14,15,16,17,18],"3010525809","",""],["2021-09-13","Furley Bioextracts SDN BHD",0,0,"","Mr. Stuart Soo","furley-bioextracts-sdn-bhd-614592-09132021","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our November 5, 2020, request, and subsequent corresponde",1,[4,6,9,13,15,16,17,18],"3008174509","",""],["2021-09-07","McDaniel Water, LLC",0,0,"","Gary McDaniel/Ruth Shields","mcdaniel-water-llc-616186-09072021","This letter is to advise you that in July 2021 the U.S. Food and Drug Administration (FDA) reviewed your product labeling and your website at the Internet address www.mcdanielwater.com and has observed that you take orders there for the product \u201cBlack Indian S",1,[16],"3015467616","",""],["2021-09-03","Databazaar.com",2,2,"","","databazaarcom-617199-09032021","",1,[17,18,19,20],"3020048549","",""],["2021-08-31","247rxpill.in",0,0,"","","247rxpillin-615313-08312021","",0,[16,17,21],"","",""],["2021-08-26","Kaleido Biosciences, Inc.",0,0,"","Daniel Menichella","kaleido-biosciences-inc-616026-08262021","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted from February 24 to March 3, 2021. Investigator Kent A. Conforti, representing FDA, reviewed the role of Kaleido Biosci",0,[],"3012884265","",""],["2021-08-24","Invisi Smart Technologies UK LTD",2,2,"","Saba Yussouf","invisi-smart-technologies-uk-ltd-614512-08242021","This is to advise you that the United States Food and Drug Administration (FDA) reviewed your websites at https://www.invisismart.com/, https://shop.invisismart.com/, and https://twitter.com/InvisiSmart on, June 21, 2021. The FDA has observed that your website",0,[17,18,19,20],"3017168126","",""],["2021-08-20","Laboratorios Dentales De Zona Franca, S.A.",2,2,"","Mr. James R. Glidewell","laboratorios-dentales-de-zona-franca-sa-607719-08202021","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS #607719, dated May 15, 2020). Based on our evaluation, it appears that you have addressed the violations contained in this War",0,[],"3001295407","",""],["2021-08-19","Mahita, LLC dba PushMyCart",0,0,"","","mahita-llc-dba-pushmycart-616541-08192021","",0,[16,17],"3019901045","",""],["2021-08-19","Toyobo Co. Ltd.",0,0,"","Mr. Hidehiko Kanae","toyobo-co-ltd-614177-08192021","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Toyobo Co. Ltd., FEI 1000251214, at Toyobo (Kabu) Sogokenkyusho, 2 Chome 1, Katata, Otsu, Shiga, from February 15 to 19, 2021, on February 22, 2021, and from February 24 to",0,[0,1,2,6,7,8,14,17,18],"1000251214","",""],["2021-08-12","Henan Lihua Pharmaceutical Co., Ltd.",0,0,"","Mr. Nui Zhigang","henan-lihua-pharmaceutical-co-ltd-548089-08122021","The food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter 320-18-58 dated June 12, 2018. Based on our evaluation, it appears that you have addressed the deviations contained in this W",0,[],"3001164052","",""],["2021-08-10","Secret of the Islands",0,0,"","Joanne Bolles","secret-islands-616344-08102021","",1,[16,17,19],"3014007900","",""],["2021-08-10","Tropicosmeticos SA de CV",0,0,"","Mr. Guillermo Jose Duarte","tropicosmeticos-sa-de-cv-609041-08102021","Your firm was registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic hand rub drug product (also referred to as consumer hand sanitizer), labeled as Britz HAND SANITIZER. This drug produc",1,[13,15,16,17,18,21],"3016764173","",""],["2021-08-09","American Preclinical Services",2,2,"","Michael Conforti, DVM, MS, MBA","american-preclinical-services-562382-08092021","The purpose of this letter is to inform you that the Food and Drug Administration (FDA) inspection conducted at your clinical site from May 10, 2021 to May 21, 2021 revealed no significant concerns. The FDA has completed an evaluation of your firm\u2019s corrective",0,[9],"3005802236","",""],["2021-08-09","Pairon Solutions LLC",2,2,"","","pairon-solutions-llc-616392-08092021","",1,[17,18,20],"3016660924","",""],["2021-08-04","BBC Group Limited",0,0,"","Mr. Alan Wong","bbc-group-limited-614659-08042021","",1,[0,5,6,14,16,17,18],"3010165327","",""],["2021-08-03","Blue Willow Biologics",0,0,"","Chad Costley, MD/MBA","blue-willow-biologics-613948-08032021","",1,[16,17,19],"3016998376","",""],["2021-07-29","Lepu Medical Technology -Beijing- Co., Ltd.",2,2,"","","lepu-medical-technology-beijing-co-ltd-614908-07292021","",1,[17,18,19,20],"3008002401","",""],["2021-07-26","Lexion Medical LLC",2,2,"","Patrick Spearman","lexion-medical-llc-613588-07262021","The United States Food and Drug Administration (FDA) has learned that your firm is marketing the AP 50/30 Insufflator, Insuflow Port, and Pneuview XE Gas Evacuation Cannula (Pneuview XE) in the United States without marketing clearance or approval, in violatio",0,[3,17,18,19,20],"3003631551","",""],["2021-07-26","Vivera Pharmaceuticals, Inc.",2,2,"","Paul Edalat","vivera-pharmaceuticals-inc-614382-07262021","",1,[17,18,19,20],"3018675346","",""],["2021-07-26","Vivera Pharmaceuticals, Inc.",2,2,"","Paul Edalat","vivera-pharmaceuticals-inc-614412-07262021","",1,[17,18,19,20],"3016713186","",""],["2021-07-22","MB Solutions, LLC/BioSpectrum CBD",0,11,"","Frederic A. Melius, MD","mb-solutions-llcbiospectrum-cbd-610649-07222021","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at www.biospectrumcbd.com and www.nasadol.com from April 2021 through July 2021 and has determined that you take orders there for several products, including \u201c",1,[16,17,18,19,20,21],"3017232376","",""],["2021-07-20","Jordan\u2019s Crossing Herbal Connections",0,0,"","","jordans-crossing-herbal-connections-616001-07202021","",1,[16,17,19],"3012609312","",""],["2021-07-20","rxmedkart.com",0,0,"","","rxmedkartcom-615763-07202021","",1,[16,17,21],"","",""],["2021-07-15","Ideal Implant Incorporated",2,2,"","Robert S. Hamas, MD","ideal-implant-incorporated-606103-07152021","The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated May 14, 2020. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future",0,[],"3008342021","",""],["2021-07-15","Sck Zeta Dis Ticaret, Pazarlama Ltd.",0,0,"","Mr. Jamal Mustafa","sck-zeta-dis-ticaret-pazarlama-ltd-610432-07152021","Your firm is registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic rub drug product (also referred to as a consumer hand sanitizer) labeled as NEUTREVO Instant Hand Sanitizer. This drug",1,[15,16,17,18,21],"3005792310","",""],["2021-07-09","Biopolygen Corp.",2,2,"","Brian Nguyen","biopolygen-corp-613137-07092021","",1,[17,18,19,20],"3017866956","",""],["2021-07-09","USH Diagnostics, Inc./covidinstanttest.net",2,2,"","Mr. Chris Ormiston","ush-diagnostics-inccovidinstanttestnet-612084-07092021","",1,[17,18,19,20],"3017666510","",""],["2021-07-08","Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil",0,0,"","Mr. Selim Yesil","delta-kozmetik-sanayi-ve-ticaret-selim-yesil-614402-07082021","Your firm is registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic hand rub drug product (also referred to as a consumer hand sanitizer), labeled as (b)(4) . This drug product was listed",0,[15,18],"3010166780","",""],["2021-07-07","Halodine, LLC",0,0,"","Jesse Pelletier, MD","halodine-llc-611150-07072021","",1,[16,17,19],"3017432659","",""],["2021-07-06","Guangzhou Minghui Cosmetics Co., Ltd.",0,0,"","Mr. Biao Chen","guangzhou-minghui-cosmetics-co-ltd-610575-07062021","Your firm recently registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic hand rub drug product (also referred to as a consumer hand sanitizer), labeled as Qi Yu\u00ae HAND SANITIZER GEL. This",1,[15,16,17,18,21],"3016753019","",""],["2021-07-02","Captain's Cloth LLC",2,2,"2021-10-07","Brian Eckert","captains-cloth-llc-613965-07022021","This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://captainscloth.com/ on June 10, 2021, where you offer the \u201cKN95 Face Mask\u201d for sale in the United States. We also reviewed your",1,[17,18,20],"3018238789","",""],["2021-07-01","Dream Pharmacy 24/7 Enterprises Limited 2018",0,0,"","","dream-pharmacy-247-enterprises-limited-2018-614898-07012021","",1,[16,17,21],"","",""],["2021-06-28","Fixture Display LLC",2,2,"2021-10-04","Mr. Alan Gao","fixture-display-llc-615052-06282021","This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.fixturedisplays.com/ on April 27, 2021. The FDA has observed that your website offers the \u201cKN95 Face Mask\u201d and \u201c3-ply Surg",1,[17,18,20],"3013288285","",""],["2021-06-28","World Packaging Solutions, LLC",2,2,"2021-10-07","Jim Sonsalla","world-packaging-solutions-llc-612824-06282021","This is to advise you that the United States Food and Drug Administration (FDA) has reviewed your website at the Internet address https://wpkgs-ppe.com/purvigor-kn95-masks/ on May 18, 2021. The FDA has observed that your website offers the \u201cPurvigor KN95 Mask\u201d",1,[17,18,20],"3017029256","",""],["2021-06-25","Davati Medical Supply LLC",1,4,"2021-10-14","Herman Cardenas","davati-medical-supply-llc-615530-06252021","",1,[16,17,19],"3019569787","",""],["2021-06-22","Pacific Center of Health/Pacific Center of Health & Acupuncture",0,0,"","Richard Gold","pacific-center-healthpacific-center-health-acupuncture-614526-06222021","",0,[16,17],"3018759590","",""],["2021-06-17","Tianjin Bolang Science-Technology Development Co., Ltd.",2,2,"","Mr. Lin Qi","tianjin-bolang-science-technology-development-co-ltd-614851-06172021","During an inspection of your firm located in Tianjin, China on March 22, 2021, through March 30, 2021, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Otoscopes, Rigid Laryngoscopes, and Rigid Na",0,[9,10,11,12,17,18,20],"3012514094","",""],["2021-06-10","Innova Medical Group, Inc.",2,2,"","Daniel J. Elliot","innova-medical-group-inc-614819-06102021","The United States Food and Drug Administration (FDA) conducted an inspection of your firm\u2019s medical device operations, Innova Medical Group, Inc., located at 800 E. Colorado Blvd., Suite 288, Pasadena, CA from March 15 through April 9, 2021. In addition, your",0,[9,10,11,13,17,18,19,20],"3018074194","",""],["2021-06-09","Natural Beauty Care Pty Ltd",0,0,"","Mr. John Dwyer","natural-beauty-care-pty-ltd-611974-06092021","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our April 16, 2020, request for records and other informa",0,[4,6,9,13,17,18],"3010164028","",""],["2021-06-07","Amplicon Land, LLC",2,2,"","Paul M. Davis","amplicon-land-llc-607975-06072021","",1,[17,18,19,20],"3005197349","",""],["2021-06-04","Zhejiang Xichen Medical Technology Co., Ltd.",2,2,"","Yinlong Dong","zhejiang-xichen-medical-technology-co-ltd-612946-06042021","This is to advise you that the United States Food and Drug Administration (FDA) has reviewed your website at the internet address https://www.xichen-med.com/ on March 23, 2021. The FDA has observed that your website offers the \u201cFFP2 NR 5-Layer KN95 Face Mask,\u201d",1,[17,18,19,20],"3016672354","",""],["2021-06-03","DMM Vission, S.A. de C.V.",0,0,"","Ma. de la Luz Escorza","dmm-vission-sa-de-cv-609797-06032021","Your firm was registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of consumer antiseptic hand rub drug products (also referred to as consumer hand sanitizers) labeled as SYP HEALTH HAND SANITIZER ALCOHOL GEL a",0,[15,16,17,18,21],"3016833130","",""],["2021-06-02","PurePurge Inc.",0,0,"","Gordon Wood","purepurge-inc-613194-06022021","This letter concerns your firm\u2019s marketing of the MEDPURE HAND SANITIZER product line 1 . The United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://purepurge.com on February 11, 2021 where you direct consumers t",0,[16,17],"3016714860","",""],["2021-06-01","RPK Pharmaceuticals Inc.",0,0,"","Rich Mangini","rpk-pharmaceuticals-inc-613400-06012021","",0,[],"2937511","",""],["2021-05-28","Nature\u2019s Distributing; Club Clean Inc/BuyMedicalMasksNow.com",2,2,"2021-10-04","","natures-distributing-club-clean-incbuymedicalmasksnowcom-613952-05282021","",1,[17,18,19,20],"3016711464","",""],["2021-05-27","Dongguan City Xinyuan Nonwoven Co., Ltd.",2,2,"2021-10-04","Mr. Alex Wong","dongguan-city-xinyuan-nonwoven-co-ltd-612354-05272021","This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address http://xinyuanmask.com/index.php/culture.html on May 19, 2021. We also reviewed your Alibaba storefront at the Internet address https:",1,[17,18,20],"3016670391","",""],["2021-05-27","Incredible Products, SA de CV",0,0,"","Diego Lomeli Pelayo","incredible-products-sa-de-cv-609503-05272021","Your firm is registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic hand rub drug product (also referred to as consumer hand sanitizer) labeled as GELBACT ANTIBACTERIAL HAND GEL. This dru",0,[15,16,17,18,21],"3009788529","",""],["2021-05-27","Irvin, Inc.",2,2,"2021-09-27","Denise Cannon","irvin-inc-612738-05272021","This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at https://theirvincorp.com/covid-19-masks/, on May 7, 2021. The FDA has observed that your website offers the \u201cIrvin KN95 PPE Mask\u201d and \u201cDisposable Face Mask",1,[2,17,18,19,20],"3017763395","",""],["2021-05-27","OCLO LLC/OCLO Nanotechnology Science",0,0,"","Ricardo Garcia","oclo-llcoclo-nanotechnology-science-614310-05272021","",0,[16,17,19],"3018571052","",""],["2021-05-21","Mask Supply Store",2,2,"2021-10-05","Fred Hakim","mask-supply-store-612585-05212021","This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://masksupply.store/ on March 12, 2021. The FDA has observed that your website offers the \u201c3 ply Surgical Mask,\u201d \u201cDisposable Prot",1,[17,18,19,20],"3017848077","",""],["2021-05-19","BGP, LLC",0,0,"","","bgp-llc-613144-05192021","",0,[16,17],"3005416825","",""],["2021-05-19","GPC Medical Ltd.",2,2,"","Vikas Narang","gpc-medical-ltd-536145-05192021","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 536145, dated October 20, 2017). Based on our evaluation, it appears that you have addressed the violations contained in thi",0,[],"3006513362","",""],["2021-05-19","Smart Women's Choice",0,0,"","Francoise Farron","smart-womens-choice-614359-05192021","This letter is to advise you that the United States Food and Drug Administration (FDA) has reviewed your product labeling, including your website at https://www.smartwomenschoice.com/, from February to April 2021 and has determined that you take orders there f",0,[16,19],"3018647558","",""],["2021-05-13","Biotek India",0,0,"","Mr. Chirag Arora","biotek-india-613295-05132021","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our April 21, 2020 request for records and other informat",0,[5,6,9,13,16,17,18],"3015394334","",""],["2021-05-13","Gulsah Uretim Kozmetik Sanayi Anonim Sirketi",0,0,"","Mr. Ali Kaya","gulsah-uretim-kozmetik-sanayi-anonim-sirketi-611591-05132021","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our April 23, 2020, request for records and other informa",0,[6,9,13,17,18],"3010734749","",""],["2021-05-07","Nikkiso Medical America, Inc",2,2,"2025-07-29","Mr. Toshihiko Kai","nikkiso-medical-america-inc-613109-05072021","The United States Food and Drug Administration (FDA) has learned that your firm is marketing the Nikkiso DBB-06 (DBB-06) in the United States without the necessary marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the A",1,[17,18,20],"3008786333","",""],["2021-05-06","Covalon Technologies Inc.",0,0,"","Brian Pedlar","covalon-technologies-inc-614350-05062021","",0,[16,17,19],"3005004019","",""],["2021-05-06","Disinfect & Shield",0,0,"","Despo Caldwell","disinfect-shield-613716-05062021","",0,[16,17],"3018121939","",""],["2021-05-06","Lauren R. Klein, MD, M.S.",0,0,"","","lauren-r-klein-md-ms-605544-05062021","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between April 9 and April 23, 2019. Investigator Sharon Matson, representing FDA, reviewed your c",1,[],"3015213291","",""],["2021-05-05","Jon B. Cole, MD",0,0,"","","jon-b-cole-md-611902-05052021","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between April 10 and April 26, 2019. Investigator Kellie L. Thommes, representing FDA, reviewed y",1,[],"3015212514","",""],["2021-05-04","Baltimore Beauty Security Square Mall",2,2,"","Yoo Kim","baltimore-beauty-security-square-mall-614182-05042021","",0,[17,18,19,20],"","",""],["2021-05-04","Ismar Soluciones Din\u00e1micas S de RL de CV",0,0,"","Mr. Alejandro Diaz","ismar-soluciones-dinamicas-s-de-rl-de-cv-609690-05042021","Your firm was recently registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic rub drug product (also referred to as a consumer hand sanitizer) labeled as OZ\u00d3 HAND SANITIZER. This drug pro",0,[15,16,17,18,21],"3017017039","",""],["2021-04-30","Angiplast Private Limited",2,2,"","Asitt B. Shah","angiplast-private-limited-607616-04302021","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 607616, May 14, 2020). Based on our evaluation, it appears that you have addressed the violations contained in this Warning",0,[],"3003348363","",""],["2021-04-27","Professional World Store",2,2,"2021-10-04","","professional-world-store-612406-04272021","",1,[17,18,20],"3017761921","",""],["2021-04-26","BMHshop",2,2,"","","bmhshop-612991-04262021","",1,[17,18,19,20],"3017718038","",""],["2021-04-26","C&G Laboratorios SA de CV",0,0,"","Mr. Yoshua Rostenberg","cg-laboratorios-sa-de-cv-610782-04262021","Your firm was registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic rub drug product (also referred to as consumer hand sanitizer) labeled as HAND SANITIZER DISINFECTANT GEL. This drug p",0,[15,16,17,18,21],"3008749537","",""],["2021-04-15","pharmacygeoff.md",0,0,"","","pharmacygeoffmd-614055-04152021","",0,[16,17,21],"","",""],["2021-04-13","Anytime COVID Test LLC",2,2,"","Steve Utley","anytime-covid-test-llc-611366-04132021","",0,[17,18,19,20],"3017473136","",""],["2021-04-13","Manhattan Stitching Company, Inc.",2,2,"2021-10-04","","manhattan-stitching-company-inc-611719-04132021","",1,[17,18,19,20],"3015113525","",""],["2021-04-13","Trinity Natural Health & Pain Management, Inc.",0,0,"","","trinity-natural-health-pain-management-inc-614007-04132021","",0,[16,17,19],"3018282452","",""],["2021-04-09","MYM Hidrominerales S.A. de C.V.",0,0,"","Mr. Alberto De La Torre","mym-hidrominerales-sa-de-cv-610066-04092021","Your firm was registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic rub drug product (also referred to as a consumer hand sanitizer), labeled as Protz real protection ANTIBACTERIAL HAND",0,[15,16,17,18,21],"3017013382","",""],["2021-04-09","Roque Plast S.A. de C.V.",0,0,"","Mr. Roque Cabrera","roque-plast-sa-de-cv-609492-04092021","Your firm was registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic hand rub drug product (also referred to as a consumer hand sanitizer) labeled as COMMAND BRANDS GEL ANITBAC INSTANT HA",0,[13,15,16,17,18,21],"3008251335","",""],["2021-04-07","About Mineral",0,0,"","Hyun Eun Lee","about-mineral-613984-04072021","",0,[16,17,19],"3018269913","",""],["2021-04-07","Allure Imports",0,8,"","Cory Chiarello","allure-imports-613211-04072021","",0,[16,17,18,19],"3015403883","",""],["2021-04-06","Sethi Laboratories",2,2,"","Mr. Sameer Sethi","sethi-laboratories-611628-04062021","",0,[17,18,19,20],"3016984341","",""],["2021-04-05","Proquimes S A Productos Quimicos Especializados S.A.",0,0,"","Mr. Francisco De la Puente","proquimes-s-productos-quimicos-especializados-sa-610069-04052021","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of active pharmaceutical ingredients (API). FDA has reviewed the records you submitted in response to our April 16, 2020, request for records and other info",0,[3,4,13,17,18],"3010165166","",""],["2021-04-01","Natural Adventure, LLC",0,0,"","Jennifer Orejobi","natural-adventure-llc-612267-04012021","",0,[16,17,19],"3014674299","",""],["2021-03-31","Neoingenium Labs, SA de CV",0,0,"","Mr. Alejandro Ortega","neoingenium-labs-sa-de-cv-610499-03312021","Your firm recently registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic hand rub drug product (also referred to as a consumer hand sanitizer) labeled as cleansepure. This drug product w",0,[15,16,17,18,21],"3013359123","",""],["2021-03-26","Fast Masks USA LLC",2,3,"","Jessica Owens","fast-masks-usa-llc-612088-03262021","",0,[17,18,19,20],"3017648958","",""],["2021-03-26","RPK Pharmaceuticals Inc.",0,0,"","Rich Mangini","rpk-pharmaceuticals-inc-613400-03262021","The United States Food and Drug Administration (FDA) has reviewed your firm\u2019s drug listing information provided to FDA\u2019s electronic Drug Registration and Listing System (eDRLS) for your drug product, \u201cclotrimazole and betamethasone dipropionate cream\u201d (NDC 530",0,[17],"2937511","",""],["2021-03-25","Ikcon Investments, Inc dba Ikcon Medical",2,2,"","Ricardo Emmanuel Weichsel Upton","ikcon-investments-inc-dba-ikcon-medical-609791-03252021","",0,[17,18,19,20],"3017167370","",""],["2021-03-24","Tresmonet Technologies, Inc., TM Testing, Inc. dba TM Technologies, Inc./TM Labs",2,2,"","Dennis Dannel","tresmonet-technologies-inc-tm-testing-inc-dba-tm-technologies-inctm-labs-610158-03242021","",0,[17,18,19,20],"3017219577","",""],["2021-03-23","Distribuidora Lagunera del Norte S.A. de C.V.",0,0,"","Mr. Gerardo Pacheco","distribuidora-lagunera-del-norte-sa-de-cv-610939-03232021","Your firm was registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a topical antiseptic drug product, labeled as weper Clean Solutions Hand Sanitizer. A representative from your company has stated that this",0,[15,16,17,18,21],"3017394466","",""],["2021-03-18","Block Scientific",2,2,"","Jeremy Linder","block-scientific-609533-03182021","",0,[17,18,19,20],"3012205358","",""],["2021-03-18","DEPQ Internacional S. de R.L de C.V.",0,0,"","Mr. Daniel Alberto Alfaro Salda\u00f1a","depq-internacional-s-de-rl-de-cv-608871-03182021","Your firm was recently registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of healthcare personnel antiseptic rub drug products, labeled as Cleanhumans Hand Sanitizer, dgreen ADVANCED HAND SANITIZER ANTIBACTER",0,[15,16,17,18],"3016788198","",""],["2021-03-12","Ravenscroft Apothecary, Inc. DBA Ravenscroft Escentials",0,0,"","Ginger Ravenscroft","ravenscroft-apothecary-inc-dba-ravenscroft-escentials-613639-03122021","",0,[16,17,19],"3018092429","",""],["2021-03-11","Albek de Mexico S.A. de C.V.",0,0,"","Mr. Jos\u00e9 Manuel Beltr\u00e1n Mendoza","albek-de-mexico-sa-de-cv-609202-03112021","Your firm is registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic rub drug product (also referred to as a consumer hand sanitizer), labeled as NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER",0,[15,16,17,18,21],"3009115034","",""],["2021-03-11","maskshell.com",2,2,"","","maskshellcom-611829-03112021","",1,[17,18,19,20],"3017588840","",""],["2021-03-11","Shenzhen Weifa Technology Co., Ltd",2,2,"2021-09-27","Huaquan Yu","shenzhen-weifa-technology-co-ltd-609828-03112021","This is to advise you that the United States Food and Drug Administration (FDA) has reviewed your website at the Internet address www.starkit.com, on February 2, 2021, where you offered the \u201cFFP1 3-ply Non-Woven EarLoop Mask\u201d and \u201cN95/FFP2 Respirator\u201d for sale",1,[17,18,20],"3016648101","",""],["2021-03-10","Dibar Nutricional S. de R.L. de C.V.",0,0,"","Mr. Jos\u00e9 Antonio D\u00edaz Barriga Ahued","dibar-nutricional-s-de-rl-de-cv-610444-03102021","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our April 22, 2020, request for records and other informa",0,[4,6,13,15,17,18],"3012040386","",""],["2021-03-10","Foshan Biours Biosciences Co., Ltd.",0,0,"","Mr. Paul Huang","foshan-biours-biosciences-co-ltd-611319-03102021","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our April 3, 2020 request, and subsequent requests, for r",0,[3,6,9,17,18],"3011474550","",""],["2021-03-05","CAMA Wellness Center/IodoRios Company, LLC",0,0,"","Elise and Max Rivers","cama-wellness-centeriodorios-company-llc-613185-03052021","",0,[16,17,19],"3018006070","",""],["2021-03-04","Cantronic Systems Inc.",2,2,"","","cantronic-systems-inc-613542-03042021","",0,[17,18,20],"3004054706","",""],["2021-03-04","Certify Global Inc.",2,2,"","Marc Potash","certify-global-inc-613568-03042021","",0,[17,18,20],"3018071931","",""],["2021-03-04","CreativeStar Solutions",2,2,"","Steven Gao/Dan Xiao","creativestar-solutions-613535-03042021","",0,[17,18,19,20],"3018071928","",""],["2021-03-04","Dubak Electrical Group",2,2,"","Vlastimir Dubak","dubak-electrical-group-613511-03042021","Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and Drug Administration (FDA) reviewed your websites at the Internet addresses https://www.duthermx.com/ and https://www.dubake",0,[17,18,19,20],"3014204295","",""],["2021-03-04","Kogniz, Inc.",2,2,"","Jed Putterman","kogniz-inc-613569-03042021","",0,[17,18,20],"3018071932","",""],["2021-03-04","Omega Engineering Inc.",2,2,"","","omega-engineering-inc-613560-03042021","Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.omega.com/ on February 19, 2021. We hav",0,[17,18,19,20],"3014540585","",""],["2021-03-04","Omnisense Systems Pte Ltd.",2,2,"","","omnisense-systems-pte-ltd-613561-03042021","",0,[17,18,19,20],"3016626146","",""],["2021-03-04","Opgal Optronic Industries Ltd.",2,2,"","Eran Bluestein","opgal-optronic-industries-ltd-613562-03042021","",0,[17,18,19,20],"3017132984","",""],["2021-03-04","Shenzhen Sunell Technology Corporation",2,2,"","Ann Wu","shenzhen-sunell-technology-corporation-613563-03042021","",0,[17,18,19,20],"3017179586","",""],["2021-03-04","Thermavis",2,2,"","Mark Norman Nightingale","thermavis-613564-03042021","",0,[17,18,19,20],"3018071929","",""],["2021-03-04","Thermoteknix System Limited",2,2,"","Richard Sydney Salisbury and Geraldine Anne Salisbury","thermoteknix-system-limited-613565-03042021","",0,[17,18,19,20],"3009028295","",""],["2021-03-04","Westminster International Ltd",2,2,"","Roger William Worrall","westminster-international-ltd-613566-03042021","",0,[17,18,19,20],"3016736153","",""],["2021-03-04","Workswell Group s.r.o.",2,2,"","Adam Svestka","workswell-group-sro-613567-03042021","",0,[17,18,19,20],"3017553454","",""],["2021-03-02","Evelyn Lopez-Brignoni, M.D.",0,0,"","","evelyn-lopez-brignoni-md-612542-03022021","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between June 8 and June 23, 2020. Ms. Angelica M. Chica, representing FDA, reviewed your conduct",0,[],"3016927347","",""],["2021-03-01","Ageless Global, LLC",0,0,"","","ageless-global-llc-612865-03012021","",0,[16,17,19],"3017912926","",""],["2021-03-01","Cannafyl",0,8,"","Mr. Edward Chaney","cannafyl-611957-03012021","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://cannafyl.com in November 2020 and has determined that you take orders there for various human and animal products, all of which",0,[16,17,18,19,21],"3015928484","",""],["2021-03-01","Gaza Proveedora De Servicios De Hospedaje Y Alimentacion",0,0,"","Mr. Luis Armando Garcia Olivares","gaza-proveedora-de-servicios-de-hospedaje-y-alimentacion-611881-03012021","Your firm was recently registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic hand rub drug product (also referred to as a consumer hand sanitizer) labeled as Pristine Hand Sanitizer Gel.",0,[15,16,17,18],"3016808324","",""],["2021-03-01","Marco Antonio Rodriguez Fierro",0,0,"","","marco-antonio-rodriguez-fierro-610110-03012021","Your firm is registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of consumer antiseptic rub drug product (also referred to as a consumer hand sanitizer), labeled as NATURAL GOLD GEL ALCOHOL ANTISEPTIC 75% Topi",0,[15,16,17,18],"3016978072","",""],["2021-03-01","Plasticos Las Palmas, S.A. de C.V",0,0,"","Sergio Akira Gonzalez Uyeda","plasticos-las-palmas-sa-de-cv-609475-03012021","Your firm was recently registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic rub drug product (also referred to as a consumer hand sanitizer) labeled as MEDICALLY MINDED Hand Sanitizer G",0,[15,16,17,18,21],"3016851785","",""],["2021-02-26","Orvic dba Webstore-USA",2,2,"","","orvic-dba-webstore-usa-610208-02262021","",0,[17,18,19,20],"3017224402","",""],["2021-02-25","Inovaker Lab S.A. de C.V.",0,0,"","Victor Manuel Escarcega Gomez","inovaker-lab-sa-de-cv-609979-02252021","Your firm recently registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a topical antiseptic drug product labeled as Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution. This drug product was label",0,[15,16,17,18],"3009028673","",""],["2021-02-22","Asesores en Mantenimiento Hidraulico e Industrial, S.A. de C.V.",0,0,"","Mr. Eduardo Romero","asesores-en-mantenimiento-hidraulico-e-industrial-sa-de-cv-610108-02222021","Your firm is registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic rub drug product (also referred to as a consumer hand sanitizer), labeled as ARGENT Defense Group HAND SANITIZER. This",0,[15,16,17,18],"3016735321","",""],["2021-02-22","Yara Elena De La Garza Perez Nieto",0,0,"","Mr. Felix Eduardo De La Garza","yara-elena-de-la-garza-perez-nieto-608697-02222021","Your firm recently registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a health care personnel antiseptic rub drug product (also referred to as a hand sanitizer), labeled as DAESI Hand Sanitizer. This drug",0,[15,16,17,18,21],"3016680234","",""],["2021-02-18","Absara Cosmetics S.A.P.I DE C.V.",0,0,"","Mr. Daniel Chamlati","absara-cosmetics-sapi-de-cv-612455-02182021","Your firm is registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic rub drug product (also referred to as a consumer hand sanitizer), labeled as FRAGRANCE FREE VLANC + PLUR HAND SANITIZER",0,[5,15,17,18],"3012333567","",""],["2021-02-17","Indus Medicare Limited",2,2,"","Pingle Janardhan Reddy","indus-medicare-limited-606159-02172021","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS #606159, dated May 4, 2020). Based on our evaluation, it appears that you have addressed the violation(s) contained in this Wa",0,[],"3003759643","",""],["2021-02-16","Dr. Paul's Lab",0,0,"","Paul Dettloff, DVM","dr-pauls-lab-612964-02162021","",0,[16,17],"3017928840","",""],["2021-02-16","KDunn and Associates, P.A. dba HealthQuilt",0,0,"","Kimberly Dunn, M.D., Ph.D.","kdunn-and-associates-pa-dba-healthquilt-611864-02162021","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted from August 4 to August 13, 2020. Investigator Iris C. MacInnes, representing FDA, reviewed the role of KDunn and Assoc",0,[16],"3017159096","",""],["2021-02-11","Evolved Ayurvedic Discoveries, Inc./BioCBDPlus",0,0,"","James Sol Radina","evolved-ayurvedic-discoveries-incbiocbdplus-609772-02112021","This letter is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.biocbdplus.com from August through October 2020 and has determined that you take orders there for \u201cBioCBD+ Total Body Care,\u201d \u201cBioCBD+ Top",0,[16,17,19,21],"3017164176","",""],["2021-02-05","Precision Analitica Integral S.A. de C.V.",0,0,"","Mr. Alan Williams","precision-analitica-integral-sa-de-cv-609784-02052021","Your firm recently registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic rub drug product (also referred to as a consumer hand sanitizer) labeled as CleanCare nogerm ADVANCED HAND SANITI",0,[13,15,16,17,18,21],"3016855928","",""],["2021-02-03","AAA Cosmetica, SA de CV",0,0,"","Mr. Albert Pla Andreu","aaa-cosmetica-sa-de-cv-609083-02032021","Your firm recently registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic rub drug product (also referred to as a consumer hand sanitizer), labeled as bio aaa ADVANCE HAND SANITIZER. This",0,[15,16,17,18,21],"3009065443","",""],["2021-02-03","Botanicals Internacional S.A. de C.V.",0,0,"","Cleman Agami","botanicals-internacional-sa-de-cv-609774-02032021","Your firm recently registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic rub drug product (also referred to as a consumer hand sanitizer), labeled as inatek HAND SANITIZER. This drug pro",0,[15,16,17,18,21],"3010166858","",""],["2021-02-03","ShangRao Chunyu Technology Co., Ltd.",0,0,"","Mr. Daniel Suer","shangrao-chunyu-technology-co-ltd-610194-02032021","Your firm is registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic rub drug product (also referred to as a consumer hand sanitizer), labeled as Instant \u2013 Hand Sanitizer \u2013 Moisturizing. T",0,[7,15,17,18],"3015958566","",""],["2021-02-02","Marci Beauty LLC",2,2,"","Shaul Rappaport","marci-beauty-llc-612041-02022021","The United States Food and Drug Administration (FDA) has learned that your firm is marketing the following light therapy devices in the United States without marketing clearance or approval: ? Jupiter ? Vega ? Neptune ? Luna ? Cosmo ? Nova ? Galaxa Under secti",1,[17,18,20],"3013874433","",""],["2021-01-29","Ignacio J. Rodriguez, MD",0,0,"","Ignacio J. Rodriguez, M.D.","ignacio-j-rodriguez-md-613002-01292021","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between August 18 and September 29, 2020. FDA Investigator Matthew F. Duff reviewed your conduct",0,[],"3012353600","",""],["2021-01-28","buy-pharma.md",0,0,"","","buy-pharmamd-611907-01282021","",0,[16,17,21],"","",""],["2021-01-28","rx2go.com",0,0,"","","rx2gocom-612391-01282021","",0,[16,17,21],"","",""],["2021-01-28","sandra-pharma.is",0,0,"","","sandra-pharmais-611909-01282021","",0,[16,17,21],"","",""],["2021-01-28","Simex Logistics S.A. de C.V.",0,0,"","Mr. Jose Ambrosio Rodriguez","simex-logistics-sa-de-cv-610529-01282021","Your firm is registered as a human drug manufacturer. The United States Food and Drug Administration (FDA) conducted testing of a consumer antiseptic rub drug product (also referred to as a consumer hand sanitizer), labeled as HEALTH & HAND GEL HAND SANITIZER.",0,[16,17,18],"3016774460","",""],["2021-01-27","Professional Compounding Centers of America dba PCCA",0,0,"2023-12-01","Mr. Fabian V. Zaccardo","professional-compounding-centers-america-dba-pcca-597638-01272021","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Professional Compounding Centers of America, Inc. (PCCA), FEI 1629694, at 9901 South Wilcrest Drive, Houston, Texas from October 22 to 29, 2019. This warning letter summari",1,[0,7,13,15,17,18],"1629694","",""],["2021-01-26","Grupo Yacana Mexico, S.A.S. de C.V.",0,0,"","Ms. Sofia Corona Gonzalez","grupo-yacana-mexico-sas-de-cv-609824-01262021","Your firm recently registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of consumer antiseptic hand rub drug products (also referred to as consumer hand sanitizers) labeled as YACANA Alcohol Antiseptic 70% Topi",0,[15,16,17,18,21],"3015123543","",""],["2021-01-25","EnMed MicroAnalytics, Inc.",2,2,"","Edwin Naylor","enmed-microanalytics-inc-610131-01252021","",0,[17,18,19,20],"3017144335","",""],["2021-01-25","Grupo Plast-Y-Kosas, SA de CV",0,0,"","Mr. Wenceslao Garcia","grupo-plast-y-kosas-sa-de-cv-609493-01252021","Your firm was registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of consumer antiseptic rub drug products (also referred to as a consumer hand sanitizer) labeled asM HAND SANITIZER, Jalisco Paper Inc. HAND SA",1,[15,16,17,18,21],"3016756400","",""],["2021-01-25","Ignacio Reyes Gonzalez",0,0,"","Ms. Rosa Yolanda Reyes Hernandez","ignacio-reyes-gonzalez-609718-01252021","Your firm was recently registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic hand rub drug product (also referred to as consumer hand sanitizer) labeled as MEDICALLY MINDED Hand Sanitize",1,[15,16,17,18,21],"3016931251","",""],["2021-01-25","Laboratorios Jaloma S.A. de C.V.",0,0,"","Mr. Jaime Labastida","laboratorios-jaloma-sa-de-cv-609287-01252021","Your firm is registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic rub drug product (also referred to as a consumer hand sanitizer) labeled as Jaloma Antiseptic Hand Sanitizer. This drug",1,[15,16,17,18,21],"3002600322","",""],["2021-01-22","Yuyao YiJia Daily Chemical Co., Ltd.",0,0,"","Mr. Zhao Liqun","yuyao-yijia-daily-chemical-co-ltd-610487-01222021","Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our March 31, 2020 request for records and other informat",1,[3,4,6,9,13,14,15,17,18],"3015592903","",""],["2021-01-04","Coco's Holistic Specialties & Apothecary",0,0,"","Janine Havins","cocos-holistic-specialties-apothecary-612001-01042021","",1,[16,17,19],"3017576255","",""],["2020-12-22","G & L Wellness, LLC",0,8,"","Lois Carter","g-l-wellness-llc-609572-12222020","This letter is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.glwellness.net in August and December 2020 and has determined that you take orders there [1] for the \u201cC BETTER DAILY Adult Regular Formul",0,[16,17,18,19,21],"3017228977","",""],["2020-12-22","New Leaf Pharmaceuticals, LLC",0,0,"","Paul Carpenter/Rod Deraney","new-leaf-pharmaceuticals-llc-609744-12222020","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.newleafpharma.com in July 2020 and determined that you took orders there for \u201cRHINODOL CBD\u201d nasal spray products (offered in 500 and 1000 mcg strengths),",0,[16,17,18,19,21],"3016543343","",""],["2020-12-22","NextL3vel Services Group, LLC dba This Stuff Is Good For You",0,11,"","Michael L. Cabarus and Ryan A. Rodriguez","nextl3vel-services-group-llc-dba-stuff-good-you-610446-12222020","This letter is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.thisstuffisgoodforyou.com in September and December 2020 and has determined that you take orders there for various human and animal produ",0,[16,17,18,19,20,21],"3017265499","",""],["2020-12-22","Wellness BioSciences Rx",0,9,"","Barry Cocheu","wellness-biosciences-rx-609604-12222020","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://wbrxglobal.com in September and December 2020, and has observed that you take orders there for \u201cWBRx Metered-Dose Inhaler,\u201d \u201cWBRx Balance Softgels CB",0,[3,16,17,18,19,20,21],"3017143895","",""],["2020-12-21","Broncolin, S.A. de C.V.",0,0,"","Jaime Ortega","broncolin-sa-de-cv-609329-12212020","Your firm is registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic rub drug product (also referred to as a consumer hand sanitizer) labeled as HERBACIL Antiseptic Hand Sanitizer. This dr",0,[15,16,17,18,21],"3009331372","",""],["2020-12-18","Rowpar Pharmaceuticals",0,0,"","James Ratcliff","rowpar-pharmaceuticals-611759-12182020","",0,[16,17,19],"3001751431","",""],["2020-12-10","Indigenous Products",0,0,"","Steve Crear","indigenous-products-610588-12102020","",0,[16,17],"3008929273","",""],["2020-12-10","iThrive.health",0,0,"","Alirio Zavarce","ithrivehealth-611790-12102020","",0,[16,17,19],"3017580862","",""],["2020-12-07","Paradigm RE LLC",0,0,"","","paradigm-re-llc-612014-12072020","",0,[16,17,19],"3017636693","",""],["2020-12-02","Rat's Army",0,0,"","","rats-army-612020-12022020","",0,[16,17,19],"3017638794","",""],["2020-12-01","Corporativo Bureli S.A. de C.V.",0,0,"","Mr. Jorge Bermudez Cardona","corporativo-bureli-sa-de-cv-610304-12012020","Your firm recently registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic rub drug product (also referred to as a consumer hand sanitizer), labeled as Soho Fresh Hand Sanitizer. This drug",0,[15,16,17,18,21],"3017066032","",""],["2020-11-30","Avazo-Healthcare, LLC",2,12,"","","avazo-healthcare-llc-610282-11302020","",0,[16,17,18,19,20],"3017232664","",""],["2020-11-23","Industry Lab Diagnostic Partners",2,2,"","Lance Benedict","industry-lab-diagnostic-partners-609602-11232020","",0,[17,18,19,20],"3017143872","",""],["2020-11-19","Liq-E S.A. De C.V.",0,0,"","Jose Luis Rodriguez","liq-e-sa-de-cv-609128-11192020","Your firm recently registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of drug product manufactured at your facility: consumer antiseptic hand rubs (also referred to as consumer hand sanitizers) labeled as Opt",0,[15,16,17,18,21],"3010653642","",""],["2020-11-18","Pro Breath MD, LLC dba Dentist Select and OraCare",0,0,"","","pro-breath-md-llc-dba-dentist-select-and-oracare-610686-11182020","",0,[16,17,19],"3017356007","",""],["2020-11-18","Vibrant Health Care, Inc.",1,4,"","Edgar Suter, MD","vibrant-health-care-inc-608426-11182020","",0,[16,17,19],"3015685627","",""],["2020-11-16","Harmonic Nature S. de R.L. MI.",0,0,"","Mr. Miguel Martinez","harmonic-nature-s-de-rl-mi-609367-11162020","Your firm is registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic hand rub drug product (also referred to as consumer hand sanitizer) labeled as Alcohol Antiseptic 75% Topical Solution",0,[15,16,17,18,21],"3013318132","",""],["2020-11-10","MXL Comercial, SA de CV",0,0,"","Fernando Padilla","mxl-comercial-sa-de-cv-609335-11102020","Your firm is registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of consumer antiseptic hand rub (also referred to as consumer hand sanitizers) labeled as Hand Sanitizer Disinfectant Gel, 70% Ethyl Alcohol. Th",0,[15,16,17,18,21],"3016908019","",""],["2020-11-06","Grupo Asimex de Mexico SA de CV",0,0,"","Mr. Rogerio Pimentel","grupo-asimex-de-mexico-sa-de-cv-609759-11062020","Your firm recently registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic rub drug product (also referred to as a consumer hand sanitizer) labeled as ANTISEPTIC Hand Sanitizer Florance Mo",0,[15,16,17,18,21],"3008944019","",""],["2020-11-06","JG Atlas Comercios, SA de CV",0,0,"","Mr. Jonathan Alonzo Gonzalez Espinoza","jg-atlas-comercios-sa-de-cv-609415-11062020","Your firm recently registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic drug product labeled as Sayab Antiseptic Hand Sanitizer. This drug product was labeled as manufactured at your fa",0,[15,16,17,18,21],"3016829724","",""],["2020-11-04","Nartex Laboratorios Homeopaticos S.A. de C.V.",0,0,"","Mr. Eduardo Acosta","nartex-laboratorios-homeopaticos-sa-de-cv-608540-11042020","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Nartex Laboratorios Homeopaticos, S.A. de C.V., FEI 3009407408, at Calzada Lazaro Cardenas 708-770, Col. Eduardo Guerra, Torreon, Coahuila de Zaragoza, from February 24 to",0,[4,13,18],"3009407408","",""],["2020-11-02","NovaBay Pharmaceuticals, Inc.",0,0,"","Justin Hall","novabay-pharmaceuticals-inc-610816-11022020","",0,[16,17,19],"3006218807","",""],["2020-10-30","Spartan Enterprises Inc. dba Watershed Wellness Center",0,0,"","Robert McCauley","spartan-enterprises-inc-dba-watershed-wellness-center-610876-10302020","",0,[16,17,19],"3012141366","",""],["2020-10-29","Asiaticon, SA de CV",0,0,"","Mr. Hector Salinas","asiaticon-sa-de-cv-609162-10292020","Your firm recently registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of testing of a consumer antiseptic hand rub drug product (also referred to as a consumer hand sanitizer) labeled as V-KLEAN HAND SANITIZE",0,[15,16,17,18,21],"3016691209","",""],["2020-10-29","Trask and Roth Inc. dba Trask & Roth Research and Manufacturing",2,2,"","Kodi Bethay-Roth","trask-and-roth-inc-dba-trask-roth-research-and-manufacturing-609565-10292020","",0,[17,18,19,20],"3017124563","",""],["2020-10-27","Real Clean Distribuciones SA de CV",0,3,"","Mr. Sammy Atri","real-clean-distribuciones-sa-de-cv-608900-10272020","Your firm recently registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of consumer antiseptic hand rubs (also referred to as consumer hand sanitizers) labeled as Born Basic Anti-Bac Hand Sanitizer. This drug p",0,[15,16,17,18,21],"3016620521","",""],["2020-10-23","4E Global, S.A.P.I. de C.V.",0,0,"","Jorge Gonz\u00e1lez Olvera","4e-global-sapi-de-cv-608940-10232020","Your firm is registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of consumer antiseptic hand rub drug products (also referred to as consumer hand sanitizers), labeled as blumen Advanced Instant Hand Sanitizer",0,[15,16,17,18,21],"3010078513","",""],["2020-10-23","Grupo Insoma, S.A.P.I de CV",0,0,"","Mr. Aldo Montera","grupo-insoma-sapi-de-cv-608768-10232020","Your firm was recently registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic hand rub (also referred to as consumer hand sanitizers), labeled as Hand Sanitizer Gel Unscented 70% Alcohol",0,[15,16,17,18,21],"3016750033","",""],["2020-10-16","For Our Vets LLC dba Patriot Supreme",0,0,"","Justin Elenburg","our-vets-llc-dba-patriot-supreme-611043-10162020","",0,[16,17,19],"3017417670","",""],["2020-10-15","LVWellness & Aesthetics",2,12,"","Justin Hogan","lvwellness-aesthetics-609821-10152020","",0,[16,17,18,19,20],"3017172003","",""],["2020-10-15","Quimica Magna de Mexico, S.A. de C.V.",0,0,"","Mr. Jorge Varela","quimica-magna-de-mexico-sa-de-cv-608751-10152020","Your firm was recently registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of consumer antiseptic drug products labeled as Datsen Hand Sanitizer and Alcohol Antiseptic 62% Topical Solution Hand Sanitizer. The",0,[14,15,16,17,18],"3016681443","",""],["2020-10-09","Shilpa Medicare Limited",0,0,"","Mr. Vishnukant Chaturbhuj Bhutada","shilpa-medicare-limited-607877-10092020","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility at Shilpa Medicare Limited, Unit-IV, FEI 3009876430, Plot No. S-20 to S-26, Pharm, Formulation SEZ, TSIIC, Green Industrial Park, Polepally (Village), Jadcherla (Mandal), Di",0,[2,5,6,7,10,14,18],"3009876430","",""],["2020-10-07","Battelle Memorial Institute",2,2,"","Jeff Rose","battelle-memorial-institute-610928-10072020","The Food and Drug Administration (FDA) authorized the Battelle Memorial Institute\u2019s (Battelle\u2019s) Critical Care Decontamination System (CCDS) under Emergency Use Authorization (EUA) EUA200210 on March 28, 2020. FDA subsequently revised and reissued the EUA on M",0,[11],"1523658","",""],["2020-10-07","Griffo Botanicals",0,0,"","Frank Griffo","griffo-botanicals-610434-10072020","",0,[16,17,19],"3017261913","",""],["2020-10-07","Prairie Dawn Herbs",0,0,"","Dawn Brooks","prairie-dawn-herbs-610877-10072020","",0,[16,17,19],"3010698648","",""],["2020-10-06","Haloderm, Inc.",0,0,"","Mr. Alexander Putris","haloderm-inc-608852-10062020","This letter is to advise you that the United States Food and Drug Administration (FDA) has reviewed your website at the Internet address www.haloderm.com and has determined that you take orders there for the products \u201cHaloDerm Regular Homeopathic Mole & Skin T",0,[16,17,18],"3016585233","",""],["2020-10-06","Oneness Labs",0,0,"","","oneness-labs-608918-10062020","This letter is to advise you that the United States Food and Drug Administration (FDA) has reviewed your website at the Internet address www.onenesslabs.com and has determined that you have taken orders there for the products \u201cOneness Labs Homeopathic Skin Tag",0,[16,17,18],"3017022440","",""],["2020-10-05","Physician 360, Inc.",2,2,"","Dr. Rob Lapporte","physician-360-inc-604202-10052020","The Food and Drug Administration (FDA) has learned that your firm is manufacturing and marketing the Physician 360 Rapid Strep Test, Physician 360 Rapid Flu Test ( collectively referred to as Physician 360 Rapid Tests), and Physician 360 COVID-19 Rapid Test in",0,[17,18,19,20],"3014662883","",""],["2020-10-01","USARxMedicine",0,0,"","","usarxmedicine-610865-10012020","",0,[16,17,21],"3017381013","",""],["2020-09-29","Tonic Therapeutic Herb Shop & Elixir Bar",0,0,"","","tonic-therapeutic-herb-shop-elixir-bar-610727-09292020","",0,[16,17,19],"3017361142","",""],["2020-09-24","LEC Custom Products, Inc.",0,0,"","Mr. Jeremy Willard","lec-custom-products-inc-607838-09242020","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, LEC Custom Products, Inc., 3004737602, at 7 Kenview Boulevard, Brampton, Ontario, from March 2 to 6, 2020. This warning letter summarizes significant violations of current",0,[3,4,6,7,10,13,14,18],"3004737602","",""],["2020-09-24","Panacea Biotec Limited",0,0,"","Dr. Rajesh Jain","panacea-biotec-limited-607837-09242020","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Panacea Biotec Limited, FEI 3007187282, at Tehsil Nalagarh, Village Malpur, Baddi, District Solan, Himachal Pradesh, from February 10 to 20, 2020. This warning letter summa",0,[1,8,18],"3007187282","",""],["2020-09-09","Pharmacy Plus, Inc. dba Vital Care Compounder",0,0,"","Ron Edwards","pharmacy-plus-inc-dba-vital-care-compounder-610477-09092020","",0,[16,17,19],"3010241801","",""],["2020-09-04","Mayon's Pharmaceuticals Pvt Ltd",0,0,"","Mr. Yusuf MH Chimthanawala","mayons-pharmaceuticals-pvt-ltd-607388-09042020","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Mayon\u2019s Pharmaceuticals, Pvt. Ltd., FEI 3010910756, at Old Kamptee Road, Behind Octroi Naka No. 4, Kalamna, Nagpur, Maharashtra from February 17 to 20, 2020. This warning l",0,[3,4,9,13,18],"3010910756","",""],["2020-09-02","alpharoyalpharmacy.com",0,0,"","","alpharoyalpharmacycom-610241-09022020","",0,[16,17,21],"","",""],["2020-09-02","beststeroidstore.net",0,0,"","","beststeroidstorenet-610247-09022020","",0,[16,17,21],"","",""],["2020-09-02","bluepillmedications.com",0,0,"","","bluepillmedicationscom-610250-09022020","",0,[16,17,21],"","",""],["2020-09-02","Extrapharma.com",0,0,"","","extrapharmacom-607931-09022020","",0,[16,17,21],"","",""],["2020-09-02","globalpharmacystores.com",0,0,"","","globalpharmacystorescom-610342-09022020","",0,[16,17,21],"","",""],["2020-09-02","Medication-house.com",0,0,"","","medication-housecom-607751-09022020","",0,[16,17,21],"","",""],["2020-09-02","melanopharmacy.com",0,0,"","","melanopharmacycom-610314-09022020","",0,[16,17,21],"","",""],["2020-09-02","Ocular Therapeutix Inc.",2,2,"","Ms. Nicole Oliynyk","ocular-therapeutix-inc-564663-09022020","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 564663, dated October 18, 2018). Based on our evaluation, it appears that you have addressed the violation(s) contained in t",0,[],"3008477155","",""],["2020-09-01","1 Party At A Time",0,0,"","Dmitry Kats","1-party-time-609781-09012020","",0,[16,17,19],"3017166483","",""],["2020-08-31","genericpharmacyusa.com",0,0,"","","genericpharmacyusacom-610252-08312020","",0,[16,17,21],"","",""],["2020-08-31","greenrxpharmacy.com",0,0,"","","greenrxpharmacycom-610254-08312020","",0,[16,17,21],"","",""],["2020-08-31","IceNetworks Ltd./www.mega-pillspharmacy.com",0,0,"","","icenetworks-ltdwwwmega-pillspharmacycom-610218-08312020","",0,[16,17,21],"","",""],["2020-08-31","klasiekpharmacy.com",0,0,"","","klasiekpharmacycom-610293-08312020","",0,[16,17,21],"","",""],["2020-08-31","lekapharma.com",0,0,"","","lekapharmacom-610220-08312020","",0,[16,17,21],"","",""],["2020-08-31","www.buydrugsmedsonline.com",0,0,"","","wwwbuydrugsmedsonlinecom-610292-08312020","",0,[16,17,21],"","",""],["2020-08-31","www.roidsforce.com",0,0,"","","wwwroidsforcecom-610217-08312020","",0,[16,17,21],"","",""],["2020-08-31","www.rxeasymeds.com",0,0,"","","wwwrxeasymedscom-610216-08312020","",0,[16,17,21],"","",""],["2020-08-31","www.skylimitpharmacy.com",0,0,"","","wwwskylimitpharmacycom-610215-08312020","",0,[16,17,21],"","",""],["2020-08-31","www.uspharmacyshop.com",0,0,"","","wwwuspharmacyshopcom-610213-08312020","",0,[16,17,21],"","",""],["2020-08-31","www.xsteroids.com",0,0,"","","wwwxsteroidscom-610203-08312020","",0,[16,17,21],"","",""],["2020-08-26","Thomas Meds",0,0,"","","thomas-meds-609075-08262020","",0,[16,17,21],"3017057025","",""],["2020-08-24","PT. MegaSurya Mas",0,0,"","Mr. Alok Kumar Jain","pt-megasurya-mas-604366-08242020","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, PT. MegaSurya Mas, FEI 3007801999, at J1 Tambak Sawah 32, Sidoarjo, Jawa Timur, from November 11 to 15, 2019. This warning letter summarizes significant violations of curre",0,[0,3,4,5,6,7,9,13,14,15,18],"3007801999","",""],["2020-08-19","Living Senior, LLC",0,0,"","Justin Hartfield","living-senior-llc-609864-08192020","",0,[16,17,19],"3017177812","",""],["2020-08-18","Pomegranate Consulting, LLC, Pomegranate Consulting, Ltd. dba Glorious One-Pot Meals",2,2,"","Elizabeth Gail Yarnell","pomegranate-consulting-llc-pomegranate-consulting-ltd-dba-glorious-one-pot-meals-608068-08182020","",0,[17,18,19,20],"3016877959","",""],["2020-08-17","PA Green Wellness LLC dba A Predictive Biotech Certified Facility",1,0,"","","pa-green-wellness-llc-dba-predictive-biotech-certified-facility-608144-08172020","",0,[16,17,19],"3012707547","",""],["2020-08-17","Predictive Biotech",1,0,"","Mr. Eric K. Olson","predictive-biotech-608322-08172020","",0,[16,17],"3012707547","",""],["2020-08-14","SilveryGuy",0,0,"","","silveryguy-609843-08142020","",0,[16,17,19],"3017175471","",""],["2020-08-13","Wintac Limited",0,0,"","Dr. Veerappan Subramanian","wintac-limited-606700-08132020","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Wintac Limited, FEI 3003821988, at 54/1 Bodhihal Village, Nelamangala, Bangalore, from February 10 to 19, 2020. This warning letter summarizes significant violations of cur",0,[1,2,7,14,18],"3003821988","",""],["2020-08-12","Banco Vida Corp.",1,4,"","Jose R. Huerta Rebozo, MD, FACOG","banco-vida-corp-606288-08122020","The United States Food and Drug Administration (FDA) conducted an inspection of your firm, Banco Vida Corporation, located at #239 Arterial Hostos Avenue, Suite 604, Capital Center Building, Torre Sur, San Juan, PR 00918, between September 9, 2019 and Septembe",0,[1,8],"3011849882","",""],["2020-08-12","Primus Corporation dba Trinity Biotech",2,2,"","Ronan O\u2019Caomigh","primus-corporation-dba-trinity-biotech-607698-08122020","",0,[12,17,18,20],"1931251","",""],["2020-08-11","Oxford Medical Instruments USA, Inc.",0,0,"","Istvan Magyar","oxford-medical-instruments-usa-inc-609104-08112020","",0,[16,17,19],"3014680732","",""],["2020-08-07","H-Lab Life",0,0,"","","h-lab-life-609528-08072020","",0,[16,17,19],"3017124473","",""],["2020-08-06","Canadian Chaga",0,0,"","","canadian-chaga-609097-08062020","",0,[16,17,19],"3017064999","",""],["2020-08-04","Soluciones Cosmeticas, SA de CV",0,0,"","Mr. David Ali","soluciones-cosmeticas-sa-de-cv-609057-08042020","Your firm recently registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of drug products manufactured at your facility: consumer antiseptic hand rubs (also referred to as consumer hand sanitizers) labeled as BE",0,[15,16,17,18,21],"3011274338","",""],["2020-08-03","MMSTabs.com",0,0,"","Terance Winson","mmstabscom-609461-08032020","",0,[16,17,19],"3017125107","",""],["2020-07-30","Vapore LLC dba Mypurmist",0,0,"","","vapore-llc-dba-mypurmist-608953-07302020","",0,[16,17,19],"3010169226","",""],["2020-07-24","ACRX Specialty Pharmacy Inc.",0,0,"","Eghomware J. Igbinovia","acrx-specialty-pharmacy-inc-609518-07242020","From February 25, 2019, to March 20, 2019, a U.S. Food and Drug Administration (FDA) investigator inspected your facility, ACRX Specialty Pharmacy, Inc., located at 3200 Soaring Gulls Drive, Suite 101, Las Vegas, NV 89129. During the inspection, our investigat",0,[1,2,14,17,18,21],"3015134033","",""],["2020-07-24","CoreMedica Laboratories, Inc.",2,2,"","Cory Zuehlsdorf","coremedica-laboratories-inc-608757-07242020","",0,[17,18,19,20],"3013537103","",""],["2020-07-24","Fair Price Labs, Inc.",2,2,"","Deryl Everette and Patricia Everette","fair-price-labs-inc-607832-07242020","",0,[17,18,19,20],"3013537103","",""],["2020-07-23","AkivaMed Inc.",2,2,"","","akivamed-inc-609211-07232020","",0,[17,18,19,20],"3017086924","",""],["2020-07-23","Eskbiochem SA de CV",0,0,"","Mr. Alexander Escamilla","eskbiochem-sa-de-cv-608690-07232020","Your firm was recently registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of drug products labeled as having been manufactured at your facility: consumer antiseptic hand rubs (also referred to as consumer han",0,[15,16,17,18,21],"3016678056","",""],["2020-07-23","Holistic Health International, LLC",2,2,"","Dr. Amy Yasko and Edward Yasko","holistic-health-international-llc-607885-07232020","",0,[17,18,19,20],"3016851462","",""],["2020-07-21","21st Century LaserMed Pain Institute d/b/a Create Wellness Clinics",1,1,"","Dr. Phillip Yoo, DC","21st-century-lasermed-pain-institute-dba-create-wellness-clinics-607654-07212020","",0,[16,17,18,19,20],"3016790509","",""],["2020-07-14","Signa SA de CV",0,0,"","Mr. Jeff Watson","signa-sa-de-cv-605219-07142020","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Signa S.A. de C.V., FEI 3002808161, at Avenida Industria Automotriz No. 301, Fracc. Delegaci\u00f3n Santa Ana Tlapaltitlan, Toluca, Toluca De Lerdo, Mexico, from December 16 to",0,[4,7,14,18],"3002808161","",""],["2020-07-13","Kegan Wellness",0,0,"","","kegan-wellness-608737-07132020","",0,[16,17,19],"3016998483","",""],["2020-07-10","Health Beauty Love",0,0,"","","health-beauty-love-608979-07102020","",0,[16,17,19],"3017038895","",""],["2020-07-09","Hydroxychloroquine-online.com",0,0,"","","hydroxychloroquine-onlinecom-607727-07092020","",0,[16,17,21],"","",""],["2020-07-09","Pharmaboosters.com",0,0,"","","pharmaboosterscom-607929-07092020","",0,[16,17,21],"3016816960","",""],["2020-07-08","Okamoto Rubber Products Co., Ltd.",2,2,"","Hideki Kaneuji","okamoto-rubber-products-co-ltd-604564-07082020","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS# 604564), dated February 14, 2020. Based on our evaluation, it appears that you have addressed the violation(s) contained in t",0,[],"3002806673","",""],["2020-07-07","Ionogen, LLC",0,0,"","","ionogen-llc-608909-07072020","",0,[16,17],"3017023712","",""],["2020-07-07","Shen Clinic, LLC",0,0,"","","shen-clinic-llc-607637-07072020","",0,[16,17,19],"3007615976","",""],["2020-07-06","Butterfly Expressions LLC",0,0,"","Laree Westover & Valaree Westover (Sharp)","butterfly-expressions-llc-608567-07062020","",0,[16,17,19],"3006211158","",""],["2020-07-06","Lianhuaqingwencaps.com",0,0,"","","lianhuaqingwencapscom-608667-07062020","",0,[16,17,19],"3016994563","",""],["2020-07-06","Lotus Herbal Supplements",0,0,"","","lotus-herbal-supplements-608658-07062020","",0,[16,17,19],"3016994540","",""],["2020-07-06","SinoTradition.com",0,0,"","","sinotraditioncom-608643-07062020","",0,[16,17,19],"3016986351","",""],["2020-07-01","M Dialysis AB",2,2,"","Olof Nord","m-dialysis-ab-554169-07012020","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 554169, dated June 6, 2018). Based on our evaluation, it appears that you have addressed the violations contained in this Wa",0,[],"3003733874","",""],["2020-06-30","Center for Wellness and Integrative Medicine",0,0,"","Tom Yarema, M.D.","center-wellness-and-integrative-medicine-608693-06302020","",0,[16,17,19],"3016994610","",""],["2020-06-29","Epro E-Commerce Limited dba DealExtreme and DX.com",2,2,"","Xiao Fei Che","epro-e-commerce-limited-dba-dealextreme-and-dxcom-607657-06292020","",0,[17,18,19,20],"3012085912","",""],["2020-06-26","Nuance Health, LLC",0,0,"","Kent New and Jennifer Sawyer New","nuance-health-llc-608405-06262020","",0,[16,17,19],"3016946652","",""],["2020-06-26","SuperHealthGuard and Loyal Great International Ltd.",0,0,"","","superhealthguard-and-loyal-great-international-ltd-608633-06262020","",0,[16,17,19],"3016986325","",""],["2020-06-25","Curativa Bay Corporation",0,0,"","William J. Maher","curativa-bay-corporation-608406-06252020","",0,[16,17],"3016946642","",""],["2020-06-19","North Isle Wellness Center",0,0,"","","north-isle-wellness-center-607947-06192020","",0,[16,17,19],"3016860064","",""],["2020-06-18","Project 1600 Inc.",0,0,"","Dennis Michael Lynch","project-1600-inc-608349-06182020","",0,[16,17,19],"3016936972","",""],["2020-06-17","KBMO Diagnostics, LLC",2,2,"","James White","kbmo-diagnostics-llc-607822-06172020","",0,[17,18,19,20],"3016693336","",""],["2020-06-17","Modern Allergy Management LLC dba Direct Med Solutions LLC",2,2,"","George Masey","modern-allergy-management-llc-dba-direct-med-solutions-llc-607769-06172020","",0,[17,18,19,20],"3016823995","",""],["2020-06-17","Vega Life Sciences Private Limited",0,0,"","Mr. Venkata Reddy Kurre","vega-life-sciences-private-limited-604469-06172020","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Vega Life Sciences Private Limited, FEI 3015658387, at Plot No. D-15, 16, 21 & 22, Phase-I, I.D.A. Pashamylaram, Patencheru (M), Sangareddy District, Telangana, from Novemb",0,[0,18],"3015658387","",""],["2020-06-15","antibodiescheck.com",2,2,"","","antibodiescheckcom-607681-06152020","",0,[17,18,19,20],"3016810062","",""],["2020-06-15","Sonrisa Family Dental dba www.mycovidtest19.com",2,2,"","Dr. Jason Korkus, DDS","sonrisa-family-dental-dba-wwwmycovidtest19com-607748-06152020","",0,[17,18,19,20],"3016823857","",""],["2020-06-11","8046255 Canada Inc. DBA Viatrexx",0,0,"","Mr. Stephen Emond","8046255-canada-inc-dba-viatrexx-596178-06112020","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, 8046255 Canada Inc., doing business as (dba) Viatrexx, FEI 3010033797, at 1360 Rue Louis-Marchand, Beloeil, from September 16 to 24, 2019. This warning letter summarizes si",0,[1,2,5,8,14,16,17,18],"3010033797","",""],["2020-06-11","Hevert Pharmaceuticals LLC USA",0,0,"","Elizabeth Spannuth","hevert-pharmaceuticals-llc-usa-594842-06112020","This letter is to advise you that the United States Food and Drug Administration (FDA) has reviewed your product labeling for your injectable products \u201cArnica,\u201d \u201cCalmvalera comp.,\u201d \u201cGelsemium comp.,\u201d \u201cHepar comp.,\u201d and \u201cLymphaden comp.,\u201d including your product",0,[16,17,18],"3015908524","",""],["2020-06-11","Medinatura Inc",0,0,"","Cathy Raish","medinatura-inc-596269-06112020","This letter is to advise you that the United States Food and Drug Administration (FDA) has reviewed your product labeling, including your website at http://hcp.medinatura.com/, from which you take orders for your injectable products \u201cZeel Injection Solution,\u201d",0,[16,17,18],"1626962","",""],["2020-06-11","World Health Advanced Technologies Ltd",0,0,"","","world-health-advanced-technologies-ltd-598247-06112020","This letter is to advise you that the United States Food and Drug Administration (FDA) has reviewed your website at enercel.com, from which you take orders for your products, \u201cEnercel AM,\u201d \u201cEnercel Forte,\u201d \u201cEnercel Max,\u201d \u201cEnercel Mist-Nasal,\u201d \u201cEnercel Mist Neb",0,[16,17,18],"3007386694","",""],["2020-06-10","Medakit Ltd",2,2,"","","medakit-ltd-607603-06102020","",0,[17,18,19,20],"3016792440","",""],["2020-06-10","www.outoftheboxremedies.com",0,0,"","John Burket","wwwoutoftheboxremediescom-608263-06102020","",0,[16,17,19],"3016920027","",""],["2020-06-09","Takeda Pharmaceutical Company Limited",0,0,"","Mr. Christophe Weber","takeda-pharmaceutical-company-limited-603596-06092020","",0,[1,2,8,14,18],"3004664162","",""],["2020-06-08","organic-beauty-recipes.com",0,0,"","Eve Cabanel","organic-beauty-recipescom-607753-06082020","",0,[16,17,19],"3016820952","",""],["2020-06-05","Creation Technologies LP",2,2,"","Michael A. Meyer","creation-technologies-lp-608364-06052020","",0,[4,9,13,18,20],"3000279201","",""],["2020-05-29","Cosmaceutical Research Lab Inc.",0,0,"","Mr. Bill Ghuman","cosmaceutical-research-lab-inc-600121-05292020","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Cosmaceutical Research Lab Inc., FEI 3003878590, at 12920 84th Avenue, Surrey, BC, Canada, from November 18 to 22, 2019. This warning letter summarizes significant violatio",0,[0,5,6,7,9,14,16,17,18],"3003878590","",""],["2020-05-28","Quadrant Sales & Marketing, Inc.",0,0,"","Robert Cefail","quadrant-sales-marketing-inc-607625-05282020","",0,[16,19],"3016790283","",""],["2020-05-28","StayWell Copper Products",0,0,"","Marcia Reece & Diana French","staywell-copper-products-607773-05282020","",0,[16,17,19],"3016824094","",""],["2020-05-26","Alternavita",0,0,"","Mary Ferrari","alternavita-607147-05262020","",0,[16,17,19],"3016716640","",""],["2020-05-26","Careful Cents, LLC",0,0,"","Carrie Lee Smith Nicholson","careful-cents-llc-607756-05262020","",0,[16,17,19],"3016821016","",""],["2020-05-26","CBD Gaze",0,3,"","","cbd-gaze-607299-05262020","",0,[16,17,19],"3016733557","",""],["2020-05-26","Musthavemom.com",0,0,"","","musthavemomcom-607749-05262020","",0,[16,17,19],"3016820731","",""],["2020-05-21","Apollo Holding LLC",0,3,"","Bryce Johnson","apollo-holding-llc-607807-05212020","",0,[16,17,19],"3016826481","",""],["2020-05-21","North Coast Biologics",1,5,"","Johnny T. Stine","north-coast-biologics-607532-05212020","",0,[16,17],"3008514611","",""],["2020-05-19","Life Unlearned, LLC",0,0,"","","life-unlearned-llc-607754-05192020","",0,[16,17,19],"3016820971","",""],["2020-05-19","SpiceTac",0,0,"","","spicetac-607144-05192020","",0,[16,17,19],"3016718098","",""],["2020-05-15","The Golden Road Kratom",0,0,"","","golden-road-kratom-607627-05152020","",0,[16,17,19],"3016796235","",""],["2020-05-15","Laboratorios Dentales De Zona Franca, S.A.",2,2,"","Mr. James R. Glidewell","laboratorios-dentales-de-zona-franca-sa-607719-05152020","During an inspection of your firm (Laboratorios Dentales De Zona Franca, S.A.) located in Cartago, Costa Rica, on January 27, 2020 through January 30, 2020, an investigator from the United States Food and Drug Administration (FDA) determined that your firm man",0,[4,9,10,13,17,18,20],"3001295407","",""],["2020-05-15","Noetic Nutraceuticals",0,0,"","","noetic-nutraceuticals-607572-05152020","",0,[16,17,19],"3016774529","",""],["2020-05-14","Allergan",2,2,"","Brent Saunders","allergan-607690-05142020","The Food and Drug Administration (FDA) approved your devices, NATRELLE Silicone-Filled Breast Implants (\u201cRound Responsive implants\u201d), under Premarket Approval (PMA) Application, P020056, and NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Brea",0,[20],"2011068","",""],["2020-05-14","Angiplast Private Limited",2,2,"","Asitt B. Shah","angiplast-private-limited-607616-05142020","During an inspection of your firm located in Ahmedbad, India on January 27, 2020, through January 30, 2020, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures urinary drainage bags. Under section 20",0,[9,13,18,20],"3003348363","",""],["2020-05-14","benjaminmcevoy.com",0,0,"","Benjamin McEvoy","benjaminmcevoycom-607149-05142020","",0,[16,17,19],"3016716643","",""],["2020-05-14","Ideal Implant Incorporated",2,2,"","Robert S. Hamas, M.D.","ideal-implant-incorporated-606103-05142020","The United States Food and Drug Administration (FDA) conducted inspection of your medical device operations at 14881 Quorum Drive, Suite 925, Dallas, Texas from January 27, 2020 through February 3, 2020, investigators from the United States Food and Drug Admin",0,[2,9,10,11,13,17,18,20],"3008342021","",""],["2020-05-14","White Eagle Native Herbs",0,0,"","Mark White Eagle","white-eagle-native-herbs-607744-05142020","",0,[16,17,19],"3016819761","",""],["2020-05-13","4nrx.md",0,0,"","","4nrxmd-606115-05132020","",0,[16,17,21],"3016608745","",""],["2020-05-13","Samchundang Pharm Co., Ltd.",0,0,"","Mr. In-Seok Chun","samchundang-pharm-co-ltd-599255-05132020","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Samchundang Pharm Co., Ltd., FEI 3008425092, at Hyangnam Pharmaceutical Industries Complex, 71 Jeyakgongdan 2-Gil, Hyangnam-Eup, Hwaseong, si Gyeonggi, from October 17 to 2",0,[1,2,5,8,18],"3008425092","",""],["2020-05-11","Fusion Health and Vitality LLC",0,0,"","Polly Ryncarz","fusion-health-and-vitality-llc-607545-05112020","",0,[16,17,19],"3016784517","Injunction","2021-01-08"],["2020-05-08","Plum Dragon Herbs, Inc.",0,0,"","Lisa Ball","plum-dragon-herbs-inc-05082020","",0,[16,17,19],"","",""],["2020-05-08","Seanjari Preeti Womb Healing, L.L.C.",0,0,"","Ivy Ruffin (Sagarius)","seanjari-preeti-womb-healing-llc-607355-05082020","",0,[16,17,19],"3014710073","",""],["2020-05-07","AgroTerra, Ltd. dba Patriot Hemp Company",0,0,"","Mr. Doug Pineda","agroterra-ltd-dba-patriot-hemp-company-606086-05072020","",0,[16,17,19],"3016595998","",""],["2020-05-07","Chronic Lyme Treatments",0,0,"","Sal Meli","chronic-lyme-treatments-607094-05072020","",0,[16,17,19],"3016619648","",""],["2020-05-07","Sanit Technologies LLC dba Durisan",0,0,"","Mr. Troy M. Daland","sanit-technologies-llc-dba-durisan-606050-05072020","",0,[16],"3014538924","",""],["2020-05-07","WashingtonsLastFrontier.Com",0,0,"","Ms. Tiffany Davidson","washingtonslastfrontiercom-606273-05072020","",0,[16,17,19],"3016622222","",""],["2020-05-06","Alive By Nature, Inc.",0,0,"","","alive-nature-inc-607435-05062020","",0,[16,17,19],"3015986368","",""],["2020-05-06","GlutaGenic",0,0,"","","glutagenic-607271-05062020","",0,[16,17,19],"3015620544","",""],["2020-05-04","Dr. Dhole's Sushanti Homeopathy Clinic",0,0,"","Dr. Nitin S. Dhole","dr-dholes-sushanti-homeopathy-clinic-607348-05042020","",0,[16,17,19],"3011108348","",""],["2020-05-04","Honey Colony LLC",0,0,"","Maryam Henein","honey-colony-llc-607346-05042020","",0,[16,17,19],"3013503096","",""],["2020-05-04","Indus Medicare Limited",2,2,"","Pingle Janardhan Reddy","indus-medicare-limited-606159-05042020","During an inspection of your firm located in Telangana, India on January 20, 2020 through January 23, 2020, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Invigra, a male natural latex condo",0,[9,11,12,17,18,20],"3003759643","",""],["2020-04-27","Hopewell Essential Oils",0,0,"","","hopewell-essential-oils-607088-04272020","",0,[16,17,19],"3016710297","",""],["2020-04-27","Santiste Labs LLC",0,0,"","","santiste-labs-llc-607227-04272020","",0,[16,17,19],"3016733542","",""],["2020-04-23","Kumar Organic Products Limited",0,0,"","Mr. K. K. Singh","kumar-organic-products-limited-598683-04232020","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Kumar Organic Products Limited, FEI 3009167769, at Plot No. 379, Canal Road, Maitri Marg, Village Luna, Taluka-Padra District, Vadodara, Gujarat, from November 11 to 14, 20",0,[2,13,18],"3009167769","",""],["2020-04-23","Prefense LLC",0,0,"","Mr. Michael Reiber","prefense-llc-605488-04232020","",0,[16],"3007545534","",""],["2020-04-22","Antroids.com",0,0,"","","antroidscom-606116-04222020","",0,[16,17],"3016608750","",""],["2020-04-22","Emedkit.com",0,0,"","","emedkitcom-606138-04222020","",0,[16,17],"3016609914","",""],["2020-04-22","Foxroids.com",0,15,"","","foxroidscom-606131-04222020","",0,[16,17],"3016608751","",""],["2020-04-22","Roidsmall.net",0,0,"","","roidsmallnet-606133-04222020","",0,[16,17],"3016608768","",""],["2020-04-21","Copper Touch, LLC",0,0,"","Linda Pavek","copper-touch-llc-607176-04212020","",0,[16,17,19],"3016710767","",""],["2020-04-20","Homero Corp DBA Natures CBD Oil Distribution",0,11,"","Mr. Michael Johnson","homero-corp-dba-natures-cbd-oil-distribution-605222-04202020","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://naturescbdoilnh.business.site/ (directs consumers to https://naturescbdoil.com/) in March 2020 and has determined that you take",0,[16,17,18,19,20,21],"3016560460","",""],["2020-04-16","Nova Botanix LTD DBA CanaBD",0,0,"","","nova-botanix-ltd-dba-canabd-606579-04162020","",0,[16,17,19],"3016655220","",""],["2020-04-16","Sooil Development Co., Ltd.",2,2,"","Ms. Yun Hee Yeom, PhD","sooil-development-co-ltd-607127-04162020","During an inspection of your firm located in Gyeonggi-do, Republic of Korea on January 20, 2020 through January 23, 2020, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the DANA Diabecare IIs in",0,[9,11,12,17,18,20],"3003024060","",""],["2020-04-15","The Art Of Cure",0,0,"","","art-cure-606596-04152020","",0,[16,17,19],"3009859997","",""],["2020-04-15","Shriram Institute for Industrial Research",0,0,"","Dr. Karampendethu Mathai Chacko","shriram-institute-industrial-research-597629-04152020","The U.S. Food and Drug Administration (FDA) inspected your contract testing laboratory, Shriram Institute for Industrial Research, FEI 3002808145, at 19 University Road, University Campus, Delhi, from October 15 to 22, 2019. This warning letter summarizes sign",0,[0,5,7,14,18],"3002808145","",""],["2020-04-14","Earth Angel Oils",0,0,"","Helen Stembridge","earth-angel-oils-605752-04142020","",0,[16,17,19],"3003941934","",""],["2020-04-13","Gaia Arise Farms Apothecary",0,0,"","Nicole Mescia","gaia-arise-farms-apothecary-606668-04132020","",0,[16,17,19],"3016661137","",""],["2020-04-13","The GBS dba Alpha Arogya India Pvt Ltd",0,0,"","Ajay Goyal","gbs-dba-alpha-arogya-india-pvt-ltd-606253-04132020","",0,[16,17,19],"3016551424","",""],["2020-04-10","Herbs of Kedem",0,0,"","","herbs-kedem-606835-04102020","",0,[16,17,19],"3016623261","",""],["2020-04-09","BIOTA Biosciences LLC",0,0,"","Patrice Romulus","biota-biosciences-llc-605164-04092020","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at biotacbd.com in February 2020 and has determined that your website provides a telephone number that customers can call to order various injectable drug produ",0,[16,17,19,21],"3016251538","",""],["2020-04-09","Earthley Wellness dba Modern Alternative Mama LLC",0,0,"","","earthley-wellness-dba-modern-alternative-mama-llc-606525-04092020","",0,[16,17,19],"3026016691","",""],["2020-04-09","Free Speech Systems LLC d.b.a. Infowars.com",0,0,"","Mr. Alexander E. Jones","free-speech-systems-llc-dba-infowarscom-605802-04092020","",0,[16,17],"3010641852","",""],["2020-04-08","Genesis 2 Church",0,0,"","Mark Grenon, Joseph Grenon, Jordan Grenon, and Jim Humble","genesis-2-church-606459-04082020","",0,[16,17,19],"3016648114","Injunction","2020-08-03"],["2020-04-08","NRP Organics Ltd",0,0,"","James Rutherford","nrp-organics-ltd-606066-04082020","",0,[16,17,19],"3016527538","",""],["2020-04-07","CBD Online Store",0,0,"","","cbd-online-store-606587-04072020","",0,[16,17,19],"3016655224","",""],["2020-04-07","Savvy Holistic Health dba Holistic Healthy Pet",0,8,"","","savvy-holistic-health-dba-holistic-healthy-pet-605915-04072020","",0,[16,17,18,19],"3016590156","",""],["2020-04-06","Alternative Health Experts LLC DBA Immunization Alternatives",0,0,"","","alternative-health-experts-llc-dba-immunization-alternatives-605884-04062020","",0,[16,17,19],"3016598453","",""],["2020-04-06","Ananda, LLC DBA Ananda Apothecary",0,0,"","Mr. Scott Merrill","ananda-llc-dba-ananda-apothecary-606163-04062020","",0,[16,17,19],"3011577681","",""],["2020-04-06","Cathay Natural, LLC",0,0,"","Ms. Cathay Fung","cathay-natural-llc-606161-04062020","",0,[16,17,19],"3016611689","",""],["2020-04-06","Indigo Naturals",0,0,"","","indigo-naturals-606423-04062020","",0,[16,17,19],"3016637469","",""],["2020-04-06","Native Roots Hemp",0,0,"","","native-roots-hemp-606247-04062020","",0,[16,17,19],"3016622737","",""],["2020-04-01","Gaia's Whole Healing Essentials, LLC",0,0,"","Mr. Michael Lamboy","gaias-whole-healing-essentials-llc-605893-04012020","",0,[16,17,19],"3016601959","",""],["2020-04-01","Health Mastery Systems DBA Pure Plant Essentials",0,0,"","Ms. KG Stiles","health-mastery-systems-dba-pure-plant-essentials-605890-04012020","",0,[16,17,19],"3016602544","",""],["2020-04-01","Homeomart Indibuy",0,0,"","Mr. Vasant Prabhu","homeomart-indibuy-605888-04012020","",0,[16,17,19],"3016601904","",""],["2020-03-31","Global Treat Srl",0,0,"","Mr. Andrei Lisinschi","global-treat-srl-596638-03312020","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Global Treat SRL, FEI 3011785267, at Str. Portullui nr. 157 Floor 2, Suite 222 Galati, Galati 800211 Romania, from September 9 to 13, 2019. This warning letter summarizes s",0,[13,14,16,18],"3011785267","",""],["2020-03-31","NeuroXPF",0,0,"","","neuroxpf-606236-03312020","",0,[16,17,19],"3016620414","",""],["2020-03-30","Bioactive C60/FullerLifeC60 LLC",0,0,"","Marshall Thurber","bioactive-c60fullerlifec60-llc-605954-03302020","",0,[16,17,19],"3005364634","",""],["2020-03-30","Halosense Inc.",0,0,"","Livia Tiba","halosense-inc-606153-03302020","",0,[16,17,19],"3016610659","",""],["2020-03-30","JRB Enterprise Group Inc. DBA Anti Aging Bed",0,0,"","Mr. John Baxter","jrb-enterprise-group-inc-dba-anti-aging-bed-605892-03302020","",0,[16,17,19],"3016601935","",""],["2020-03-30","Unitedpharmacies.md",0,0,"","","unitedpharmaciesmd-605686-03302020","",0,[16,17],"","",""],["2020-03-26","Carahealth",0,0,"","Carina Harkin","carahealth-605826-03262020","",0,[16,17,19],"3013944659","",""],["2020-03-26","Corona-cure.com",0,0,"","","corona-curecom-605875-03262020","",0,[16,17,19],"3016599797","",""],["2020-03-26","University of Kentucky",2,2,"","Joseph B. Zwischenberger, M.D.","university-kentucky-600258-03262020","This Warning Letter is to inform you of objectionable conditions observed during the Food and Drug Administration (FDA) inspection conducted at the University of Kentucky (UK) laboratory from November 4, 2019 to November 21, 2019, by an investigator from the F",0,[9,20],"3015850629","",""],["2020-03-25","Pfizer Healthcare India Private Limited",0,0,"","Mr. Albert Bourla","pfizer-healthcare-india-private-limited-594972-03252020","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Pfizer Healthcare India Private Limited, FEI 3008316085, at Plots 116-117-118-119-111-123 (part), Jawaharlal Nehru Pharma City, Parawada, Visakhapatnam, Andhra Pradesh, Ind",0,[0,2,7,8,15,18],"3008316085","",""],["2020-03-16","Invitrx Therapeutics Inc.",1,4,"","Habib (nmi) Torfi","invitrx-therapeutics-inc-581182-03162020","",0,[1,2,3,8,14],"3015252551","",""],["2020-03-13","Hangzhou Linkeweier Daily Chemicals Co., Ltd.",0,0,"","Mr. Zhang Wenbing","hangzhou-linkeweier-daily-chemicals-co-ltd-595492-03132020","",0,[2,4,6,7,13,18],"3014324616","",""],["2020-03-10","DermaPharm A/S",0,0,"","Mr. Brian Mollcrup","dermapharm-596662-03102020","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, DermaPharm A/S, FEI 3005947959, at Europavej 10, Farup, Denmark from September 16 to 19, 2019. This warning letter summarizes significant violations of current good manufac",0,[4,13,14,18],"3005947959","",""],["2020-03-10","Windlas Healthcare Private Limited",0,0,"","Mr. Hitesh Windlass","windlas-healthcare-private-limited-595494-03102020","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Windlas Healthcare Private Limited, FEI 3005339091, at Plot No. 183 & 192, Mohabewala Industrial Area, Dehradun, from August 26 to 30, 2019. This warning letter summarizes",0,[0,6,7,14,18],"3005339091","",""],["2020-03-09","Chongqing Pharma Research Institute Co., Ltd.",0,3,"","Mr. Leng Minghui","chongqing-pharma-research-institute-co-ltd-515080-03092020","The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter: 320-17-24 dated February 14, 2017. Based on our evaluation, it appears that you have addressed the deviations contained in t",0,[],"3011903543","",""],["2020-03-06","Cane S.p.A.",2,3,"","Claudio Cane","cane-spa-453171-03062020","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective and preventive actions in response to our Warning Letter (WL) dated July 29, 2015. Based on our evaluation, it appears that your firm has adequately addressed the viol",0,[9],"3003098013","",""],["2020-03-06","Colloidal Vitality LLC/Vital Silver",0,0,"","Jennifer Hickman","colloidal-vitality-llcvital-silver-604885-03062020","",0,[16,17,19],"3016548536","",""],["2020-03-06","GuruNanda LLC",0,0,"","Mr. Puneet Nanda","gurunanda-llc-604930-03062020","",0,[16,17,19],"3014468707","",""],["2020-03-06","Quinessence Aromatherapy LTD",0,0,"","Geoff Lyth","quinessence-aromatherapy-ltd-605013-03062020","",0,[16,17,19],"3016530400","",""],["2020-03-06","Vivify Holistic Clinic",0,0,"","David Raes","vivify-holistic-clinic-604883-03062020","",0,[16,17,19],"3016457658","",""],["2020-03-06","Xephyr, LLC dba N-Ergetics",0,0,"","Brad Brand, Derill J. Fussell, and Linda Fussell","xephyr-llc-dba-n-ergetics-604588-03062020","",0,[16,17,19],"3013861086","Injunction","2020-10-30"],["2020-03-02","E-Care Technology Corp.",2,2,"","Mr. Kun-Yuan Ko","e-care-technology-corp-605117-03022020","During an inspection of your firm located in Chubei City, Taiwan on October 22, 2019 through October 25, 2019, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Swaive Thermometer. Under sectio",0,[5,10,11,12,17,18,20],"3007557677","",""],["2020-02-28","FICOSOTA LTD",0,0,"","Mr. Krasen Kyurkchiev","ficosota-ltd-594591-02282020","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, FICOSOTA LTD., FEI 3014115921, at Madara Boulevard 48, Shumen, Shumen, from September 2 to 5, 2019. This warning letter summarizes significant violations of current good ma",0,[4,6,7,9,13,14,15,18],"3014115921","",""],["2020-02-27","James R. Corbett, M.D.",0,0,"","James R. Corbett, M.D.","james-r-corbett-md-603967-02272020","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between June 26 and July 8, 2019. Ms. Andrace Deyampert, representing FDA, reviewed your conduct",0,[],"3015275715","",""],["2020-02-27","Kennedy, Philip R.",2,2,"","Philip R. Kennedy, MD, PhD","kennedy-philip-r-597587-02272020","This Warning Letter is to inform you of objectionable conditions observed during the Food and Drug Administration (FDA) inspection conducted at your clinical site from October 2, 2019, to October 16, 2019, by investigators from the FDA\u2019s Office of Bioresearch",0,[9,20],"3007184242","",""],["2020-02-25","Cipla Limited",0,0,"","Mr. Umang Vohra","cipla-limited-597511-02252020","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Cipla Limited, FEI 3004081307, at L138; Ll39 - 146; L147/A; L147/1 - 147/3; S103 - 105; S107 - 112; M61 - 63, Verna, Goa, from September 16 to 27, 2019. This warning letter",0,[1,2,3,7,8,14,18],"3004081307","",""],["2020-02-14","Essnd Global",0,0,"","Mr. Suresh Chilakalpudi","essnd-global-595850-02142020","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Essnd Global, FEI 3014466792, at C-176 Maharashtra Industrial Development Corp. (MDIC), Sinnare, Nashik, Maharashtra, India, from September 9 to September 13, 2019. This wa",0,[6,7,13,14,18],"3014466792","",""],["2020-02-14","Okamoto Rubber Products Co., Ltd.",2,2,"","Mr. Hideki Kaneuji","okamoto-rubber-products-co-ltd-604564-02142020","During an inspection of your firm located in Klongluang, Pathumthani, Thailand on November 4, 2019, through November 7, 2019, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures lubricated natural ru",0,[4,9,18,20],"3002806673","",""],["2020-02-13","JHS Svendgaard Hygiene Products Ltd",0,0,"","Mr. Nikhil Nanda","jhs-svendgaard-hygiene-products-ltd-593473-02132020","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, JHS Svendgaard Hygiene Products Ltd., FEI 3009223273, at Trilokpur Road, Kheri, Kala-Amb, Sirmour, Hirnachal Pradesh, from August 19 to 22, 2019. This warning letter summar",0,[3,4,5,7,13,14,15,18],"3009223273","",""],["2020-02-13","Yibin Lihao Bio-technical Co., Ltd.",0,0,"","Mr. Xiuguo Tuo","yibin-lihao-bio-technical-co-ltd-592503-02132020","The U.S. Food and Drug Administration (FDA) conducted an inspection at Yibin Lihao Biotechnical Co., Ltd, FET 3008846564, at Number 5 Binjiang Road, Luolong Industrial Central Park. Yibin, Sichuan, from July 31 to August 6, 2019. This warning letter summarizes",0,[0,14,15,18],"3008846564","",""],["2020-02-12","Bedfont Scientific, Ltd.",2,2,"","Mr. Jason Smith","bedfont-scientific-ltd-604311-02122020","During an inspection of your firm located in Maidstone, Kent, United Kingdom, on October 28, 2019 through October 31, 2019, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures carbon monoxide gas ana",0,[9,12,18,20],"3002806497","",""],["2020-02-11","Chemland Co., Ltd.",0,0,"","Mr. Beom Zoo Lee","chemland-co-ltd-593158-02112020","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Chemland Co., Ltd, FEI 3010165627, at 77 Gaejeongsaneopdanji-ro, Miyang-myeon, Anseong-si, Gyeonggi-do, from August 19 to 22, 2019. This warning letter summarizes significa",0,[0,3,4,6,7,14,15,18],"3010165627","",""],["2020-02-03","Mandelay Kft",2,2,"","Mr. Korn\u00e9l T\u00f3kics","mandelay-kft-603799-02032020","During an inspection of your firm located in Tokol, Pest, 2316 Hungary on October 14, 2019 through October 17, 2019, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Scientific Consciousness Int",0,[12,18,20],"3010452718","",""],["2020-02-03","Steiner Biotechnology, LLC",2,2,"","Gregory G. Steiner, DDS","steiner-biotechnology-llc-592280-02032020","This Warning Letter is to inform you of objectionable conditions observed during the Food and Drug Administration (FDA) inspection conducted at Steiner Biotechnology from June 24, 2019 to June 28, 2019, by an investigator from the FDA\u2019s Office of Bioresearch M",0,[9,20],"3005138409","",""],["2020-01-23","Guangzhou Tinci Materials Technology Co., Ltd.",0,3,"","Mr. Jinfu Xu","guangzhou-tinci-materials-technology-co-ltd-592199-01232020","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Guangzhou Tinci Materials Technology Co., Ltd., FEI 3007544618, at 8th Kangda Road, Yunpu Industrial Zone, Huangpu District, Guangzhou, from July 29 to August 2, 2019. This",0,[4,14,15,18],"3007544618","",""],["2020-01-22","Sunstar Guangzhou Ltd.",0,0,"","Mr. Lianlong Xu","sunstar-guangzhou-ltd-592906-01222020","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Sunstar Guangzhou Ltd., FEI 3009449945, at Blk D, 5/F, 203 Conbo Avenue, Free Trade Zone, Guangzhou, Guangdong, from June 24 to 28, 2019. This warning letter summarizes sig",0,[2,5,13,14,15,18],"3009449945","",""],["2020-01-16","Dental-Kosmetik GmbH & Co. KG",0,0,"","Ms. Britt N. Schendekehl","dental-kosmetik-gmbh-co-kg-591351-01162020","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Dental-Kosmetik GmbH & Co., FEI 3001623034, at Katharinenstr. 4, Dresden from July 15 to 19, 2019. This warning letter summarizes significant violations of current good man",0,[4,6,7,9,13,14,18],"3001623034","",""],["2020-01-14","Philosys Co. Ltd",2,2,"","In Hwan Choi","philosys-co-ltd-582516-01142020","During an inspection of your firm located in Gunsan-si, Korea on August 27-30, 2018, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Self-Monitoring Blood Glucose (SMBG) test systems. Under secti",0,[6,10,11,17],"3010172486","",""],["2020-01-09","Cosmelab Co Ltd",0,0,"","Mr. Jin Young Park","cosmelab-co-ltd-590480-01092020","The U.S. Food and Drug Administration (FDA) inspected your facility, Cosmelab Co., Ltd., FEI 3009647084, at 4F CL Building, 42, Teheran-ro 28-gil, Oangnam-gu, Seoul, from July 15 to 17, 2019. This warning letter summarizes significant violations of current goo",0,[7,9,13,14,18],"3009647084","",""],["2020-01-09","Huaian Zongheng Bio-Tech Co., Ltd",0,0,"","Mr. Lin Li","huaian-zongheng-bio-tech-co-ltd-590789-01092020","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Huaian Zongheng Bio-Tech Co., Ltd., FEI 3007628845, at No. 615 North Xiangyu Road, Huaian, from July 1 to 5, 2019. This warning letter summarizes significant violations of",0,[4,6,13,18],"3007628845","",""],["2020-01-09","Zhuhai Aofute Medical Technology Co., Ltd.",0,0,"","Mr. Guilin Wu","zhuhai-aofute-medical-technology-co-ltd-590945-01092020","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Zhuhai Aofute Medical Technology Co., Ltd., FEI 3013761135, at Room 202, Building 2, No. 33, Yongnan Road, Zhuhai, from July 15 to 18, 2019. This warning letter summarizes",0,[0,4,9,13,14,15,16,17,18,21],"3013761135","",""],["2019-12-31","James Findling",0,0,"","James W. Findling, M.D.","james-findling-598944-12312019","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between July 11 and August 2, 2019. Investigator Denise L. Burosh, representing FDA, reviewed you",0,[],"3015358337","",""],["2019-12-23","Apollo Health And Beauty Care, Inc.",0,0,"","Mr. Charles Wachsberg","apollo-health-and-beauty-care-inc-593033-12232019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Apollo Health and Beauty Care, Inc., FEI: 3003173295, at 1 Apollo Place, North York, Ontario from August 12 to August 16, 2019. This warning letter summarizes significant v",0,[0,4,7,14,15,18],"3003173295","",""],["2019-12-20","Global Medical Technology SL",2,2,"","Fernando Lasso G\u00e9nova","global-medical-technology-sl-598226-12202019","During an inspection of your firm located in San Sebastian De Los Reyes Madrid, Spain, on October 7, 2019 through October 10, 2019, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Platinum GM",0,[9,10,11,12,17,18,20],"3011897170","",""],["2019-12-19","CGA Limited",0,0,"","Mr. Philippe Agostini","cga-limited-589028-12192019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, CGA Limited, FEI 3008527957, at Eastern Main Road, Laventille, from May 27 to 31, 2019. This warning letter summarizes significant violations of current good manufacturing",0,[3,6,13,16,17,18],"3008527957","",""],["2019-12-17","GPT Pharmaceuticals Private Ltd",0,0,"","Mr. Ashok Adityan","gpt-pharmaceuticals-private-ltd-590938-12172019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, GPT Pharmaceuticals Pvt. Ltd., FEI 3008311641, at Plot No. 6/3, Road No. 11, Nacharam, Hyderabad, from June 24 to 28, 2019. This warning letter summarizes significant viola",0,[0,6,7,13,14,18],"3008311641","",""],["2019-12-13","Baja Fur S.A. de C.V.",0,0,"","Mr. Eric Chen","baja-fur-sa-de-cv-590791-12132019","The U.S. Food and Drug Administration (FDA) inspected the site procured by Baja Fur S.A. de C.V., FEI 3012285699, at Avenida Alejandro Graham Bell 19296, Zona Cerril General, C.P. 22163, Tijuana, Mexico from July 8 to 12, 2019. where Mark wins Beauty Brands, I",0,[2,3,7,14,15,18],"3012285699","",""],["2019-12-06","Wild Child WA Pty Ltd.",0,0,"","Ms. Leanne Preston","wild-child-wa-pty-ltd-589463-12062019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Wild Child WA Pty Ltd., FEI 3006210769, at 2 Action Road, Malaga, Western Australia, from May 27 to 31, 2019. This warning letter summarizes significant violations of curre",0,[3,4,13,18],"3006210769","",""],["2019-12-05","Tismor Health and Wellness Pty Limited",0,0,"","Mr. Tony Siracusa","tismor-health-and-wellness-pty-limited-588104-12052019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Tismor Health and Wellness Pty Limited, FEI 3008932054, at 19a Garema Cct, Kingsgrove, from May 20 to 24, 2019. This warning letter summarizes significant violations of cur",0,[0,4,14,15,16,17,18],"3008932054","",""],["2019-12-03","Henan Kangdi Medical Devices Co. Ltd",0,0,"","Mr. Qi Lei","henan-kangdi-medical-devices-co-ltd-587699-12032019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Henan Kangdi Medical Devices Co. Ltd., 3009271465, at SME Pioneer Park, No. 4, 2nd Area, Zhoukou, Henan, from March 4 to 7, 2019. This warning letter summarizes significant",0,[6,13,14,16,17,18],"3009271465","",""],["2019-12-03","USHIO Europe B.V.",2,2,"","Hideaki Onishi","ushio-europe-bv-596106-12032019","During an inspection of your firm located in Bavaria, Germany on August 19 \u2013 23, 2019, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures UV lamps. Under section 201(h) of the Federal Food, Drug, an",0,[4,9,18,20],"3425","",""],["2019-11-27","Ningbo BST Clean and Care Products Co., Ltd",0,0,"","Mr. Jack Wang","ningbo-bst-clean-and-care-products-co-ltd-587788-11272019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Ningbo BST Clean and Care Products Co., Ltd., FEI 3008350682, at Xining Road, Xiwu Economic Development Zone, Fenghua, Ningbo Zhejiang, from June 10 to 14, 2019. This warni",0,[3,6,10,14,15,18],"3008350682","",""],["2019-11-22","Bella Rose Labs",0,13,"","Audriana D. Castro","bella-rose-labs-594246-11222019","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.bellaroselab.com in November 2019 and has determined that you take orders there for \u201cBELLA ROSE HEMP OIL,\u201d \u201cCBD HEMP FACIAL MOISTURIZER,\u201d \u201cCBD ISOLATE,\u201d",0,[3,16,17,18,19,20,21],"3015861842","",""],["2019-11-22","Infinite Product Company LLLP DBA Infinite CBD",0,0,"","John Ramsay","infinite-product-company-lllp-dba-infinite-cbd-593175-11222019","This letter is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.infinitecbd.com in September 2019 and has determined that you take orders there for the products \u201cAbsolute Zero 99% + CBD Isolate,\u201d \u201cFree",0,[16,17,18,19,20,21],"3015672788","",""],["2019-11-22","KOI CBD LLC",0,3,"","Brad Ridenour","koi-cbd-llc-593391-11222019","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://koicbd.com in September 2019 and has determined that you take orders there for the products \u201cCBD HEALING BALM,\u201d \u201cCBD VAPE OIL,\u201d \u201cFULL SPECTRUM CBD TI",0,[16,17,18,19,20,21],"3015153475","",""],["2019-11-22","Mr. Pink Collections, LLC",0,0,"","Qiang Hu","mr-pink-collections-llc-593395-11222019","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.mrpinkcbd.com in September 2019 and has determined that you take orders there for the products \u201cCBD Oil Drops\u201d (various sizes and flavors), \u201cCBD Gummies,",0,[16,17,18,19,20,21],"3013631470","",""],["2019-11-22","Noli Oil, LLC",0,0,"","Heather King","noli-oil-llc-593497-11222019","This letter is to advise you that the U.S. Food and Drug Administration (FDA or Agency) reviewed your website at https://nolioil.com in September 2019 and has determined that you take orders there for the products \u201cCBD Oil,\u201d \u201cCBD Oil Infused Balm,\" \u201cCBD Roll-o",0,[16,17,18,19,20,21],"3015831279","",""],["2019-11-22","Sunflora, Inc./The CBD Store, LLC dba Your CBD Store",0,0,"","Marcus Quinn","sunflora-incthe-cbd-store-llc-dba-your-cbd-store-585390-11222019","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://sunflora.org from July through October, 2019, and has determined that you take orders there for the products \u201cSunmed Tincture\u201d (also referred to as \u201c",0,[16,17,18,19,20,21],"3022429241","",""],["2019-11-22","Whole Leaf Organics, LLC",0,0,"","Jane Kim","whole-leaf-organics-llc-593176-11222019","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.wholeleaforganics.com in September 2019 and has determined that you take orders there for the products \u201cCBD-EX,\u201d \u201cCBD MAX 1000 mg,\u201d \u201cCBD-RX,\u201d \u201cCBD Defend",0,[16,17,18,19,21],"3015810316","",""],["2019-11-18","EPH Technologies, Inc.",0,0,"","Ms. Tammie Saunders","eph-technologies-inc-590707-11182019","This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at the Internet addresses www.xtremoplex.com and www.detoxoplex.com both of which redirect to www.ephbiotech.com in August 2019 and has determined that you take order",0,[16,17,19,21],"3015603814","",""],["2019-11-15","Pure Source LLC",0,0,"","Joel J. Meyerson","pure-source-llc-555240-11152019","",0,[],"3002754162","",""],["2019-11-13","East Jefferson General Hospital",2,2,"","Lance Rouse","east-jefferson-general-hospital-595999-11132019","On January 08, 2019, a representative of the State/Commonwealth of Louisiana, acting on behalf of the Food and Drug Administration (FDA) inspected your facility. This inspection revealed a serious problem involving the conduct of mammography at your facility.",0,[],"1000521307","",""],["2019-11-06","Greenbrier International, Inc dba Dollar Tree",0,0,"","Mr. Gary M. Philbin","greenbrier-international-inc-dba-dollar-tree-574706-11062019","The U.S. Food and Drug Administration (FDA) inspected your corporate headquarters, Greenbrier International, Inc. (Greenbrier) (FEI 3005269673) at 500 Volvo Parkway, Chesapeake, Virginia, from January 14 to 18, 2019 after FDA inspections revealed violative con",0,[18],"3005269673","",""],["2019-10-29","Cadila Healthcare Limited",0,0,"","Mr. Pankaj R. Patel","cadila-healthcare-limited-584856-10292019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Cadila Healthcare Limited, FEI 3002984011, at 419 & 420 8a Village-Moraiya, Ahmedabad, from April 22 to May 3, 2019. This warning letter summarizes significant violations o",0,[1,2,3,8,9,14,18],"3002984011","",""],["2019-10-28","Yino, Inc.",0,0,"","Mr. Huaijun Yin","yino-inc-578566-10282019","The U.S. Food and Drug Administration (FDA) inspected your facility, Yino Inc. at 2 Cuiping Erxiang, Yubei District, Chongqing, from March 18 to 22, 2019. This warning letter summarizes significant deviations from current good manufacturing practice (CGMP) for",0,[14,18],"3015238172","",""],["2019-10-11","TriMed, Inc.",2,2,"","David H. Medoff","trimed-inc-494255-10112019","The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated June 30, 2016. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future",0,[],"3001236812","",""],["2019-10-10","Rooted Apothecary LLC",0,0,"","Mr. Ryan P. Collett and Mr. Cade Copeland","rooted-apothecary-llc-585312-10102019","This letter is to advise you that the Food and Drug Administration (FDA or Agency) reviewed your website at the Internet address www.rootedapoth.com in July 2019 and has determined that you take orders there for various products that claim to contain cannabidi",0,[16,17,21],"3015457414","",""],["2019-10-09","Coral Pharmaceuticals LTD",0,0,"","Ms. Eleanor Palmer","coral-pharmaceuticals-ltd-586576-10092019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Coral Pharmaceuticals Ltd, FEI 3003301821, at 20 Longwood Road, Freeport City, from May 20 to 24, 2019. This warning letter summarizes significant violations of current goo",0,[4,13,14,18],"3003301821","",""],["2019-10-08","Torrent Pharmaceuticals Limited",0,0,"","Mr. Samir Mehta","torrent-pharmaceuticals-limited-585255-10082019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Torrent Pharmaceuticals Limited, FEI 3005029956, at Ahmedabad-Mehsana Highway, Taluka-Kadi, Indrad, Gujarat from April 8 to 16, 2019. This warning letter summarizes signifi",0,[4,7,9,14,18],"3005029956","",""],["2019-10-03","Bingbing Pharmaceutical Co., Ltd",0,0,"","Mr. Zhimin Yu","bingbing-pharmaceutical-co-ltd-584327-10032019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Bingbing Pharmaceutical (Hubei) Co. Ltd., FEI 3014538973, at No. 698 Bingbing Road, Economic Development Zone, Shiyan, Hubei, from May 7 to 10, 2019. This warning letter su",0,[0,3,6,14,18],"3014538973","",""],["2019-10-03","Glenmark Pharmaceuticals Limited",0,0,"","Glenn Saldanha","glenmark-pharmaceuticals-limited-582701-10032019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Glenmark Pharmaceuticals Limited, FEI 3005757050, at Village Kishanpura, Baddi Nalagarh Road, Baddi Solan, Himachal Pradesh, from April 15 to 20, 2019. This warning letter",0,[6,7,14,18],"3005757050","",""],["2019-09-26","NuCare Pharmaceuticals Inc",0,0,"","Jasmine Contreras","nucare-pharmaceuticals-inc-588096-09262019","The United States Food and Drug Administration (FDA) has manually reviewed over 200 of your firm\u2019s listing files from August 2017 to the present and has identified many instances where the listing information failed to comply with the applicable requirements.",0,[17],"3003294404","",""],["2019-09-20","Dongguan Microview Medical Technology Co., LTD",2,2,"","Mr. Ming Fai Sham","dongguan-microview-medical-technology-co-ltd-592414-09202019","During an inspection of your firm located in Guangdong, China on June 24, 2019 through June 27, 2019, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the MicroView Disposable Endoscopic Cannula.",0,[2,4,9,12,18,20],"3010608077","",""],["2019-09-20","Drug Depot, Inc., dba APS Pharmacy",0,0,"","Jaime A. Rios","drug-depot-inc-dba-aps-pharmacy-501069-09202019","",0,[],"3010621916","",""],["2019-09-12","Dermameal Co., Ltd.",0,0,"","Mr. Kim Hong-Seop","dermameal-co-ltd-582118-09122019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Dermameal Co., Ltd. at 5, Dangjeong-ro, 60beon-gil, Gunpo-si Gyeonggi-do, from March 25 to 29, 2019. This warning letter summarizes significant violations of current good m",0,[2,3,4,6,7,9,13,14,18],"3013144674","",""],["2019-09-10","Jiangsu NHWA Pharmaceutical Co., Ltd.",0,0,"","Mr. Sun Jia Quan","jiangsu-nhwa-pharmaceutical-co-ltd-582511-09102019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Jiangsu NHWA Pharmaceutical Co., Ltd. ( Jiawang site) , FEI 3005619485, at No. 6 Tianyong Road, Industrial Park, Xuzhou, Jiangsu, from April 1 to 5, 2019. This warning lett",0,[5,6,7,10,14,18],"3005619485","",""],["2019-09-10","Lupin Limited",0,0,"","Ms. Vinita D. Gupta","lupin-limited-572345-09102019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Lupin Limited Unit 1 (FEI 3002807511) at Unit 1, 198-202 New Ind Area No 2, Mandideep, Madhya Pradesh, from November 26 to December 4, 2018. This warning letter summarizes",0,[3,4,7,14,18],"3002807511","",""],["2019-09-09","Susan P. King-Harris, D.P.M.",0,21,"","Susan P. King-Harris, DPM","susan-p-king-harris-dpm-591682-09092019","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between April 29 and May 9, 2019. Investigator Andrace Deyampert, representing FDA, reviewed your",0,[],"3008695101","",""],["2019-09-06","Divyata",0,0,"","","divyata-09062019","",0,[16,17,21],"","",""],["2019-09-06","Euphoria Healthcare Pvt Ltd.",0,0,"","","euphoria-healthcare-pvt-ltd-09062019","",0,[16,17,21],"","",""],["2019-09-06","JCM Dropship",0,0,"","","jcm-dropship-09062019","",0,[16,17,21],"","",""],["2019-09-06","Meds4U",0,0,"","","meds4u-09062019","",0,[16,17,21],"","",""],["2019-08-29","Hangzhou Badi Daily Use Chemical Company",0,0,"","Mr. Jiashun Wang","hangzhou-badi-daily-use-chemical-company-580819-08292019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Hangzhou Badi Daily Use Chemical Company (FEI 3008481002) at No. 56 Shuguang Road, Yuyue Town, Huzhou City, Zhejiang Province from March 19 to 21, 2019. This warning letter",0,[3,4,6,13,16,17,18],"3008481002","",""],["2019-08-29","Shanghai Institute of Pharmaceutical Industry",0,0,"","Ms. Hongjuan Pan","shanghai-institute-pharmaceutical-industry-574821-08292019","The U.S. Food and Drug Administration (FDA) notified your site , Shanghai Institute of Pharmaceutical Industry at No. 285 Gebaini Road, Pudong District, Shanghai, of a planned surveillance and pre-approval inspection of your drug product testing facility from",0,[18],"3002808132","",""],["2019-08-29","Won Industry Co. LTD",2,2,"","Ji Hoon Yang","won-industry-co-ltd-582071-08292019","During an inspection of your firm located in Siheung-si, Republic of Korea from April 8, 2019, through April 11, 2019, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Morning Life Compression",0,[9,10,11,12,17,18,20],"3005515255","",""],["2019-08-28","Abington Memorial Hospital, IRC",1,4,"","G. Chris Christensen III","abington-memorial-hospital-irc-576854-08282019","The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter CBER-19-02 dated June 24, 2019. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Lette",0,[],"2523696","",""],["2019-08-27","IDT Australia Ltd.",0,0,"","Dr. David Sparling","idt-australia-ltd-547605-08272019","The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter: 320-18-55 dated May 23, 2018. Based on our evaluation, it appears that you have addressed the violations and deviations cont",0,[],"3000219354","",""],["2019-08-22","Polimeros y Servicios S.A.",0,0,"","Dr. Enrique Feoli","polimeros-y-servicios-sa-586323-08222019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Polimeros y Servicios S.A. at Parque Industrial Condal, Calle Pantano, Tibas, San Jose, from February 4 to 8, 2019. This warning letter summarizes significant violations of",0,[3,4,6,13,16,17,18,21],"3011778211","",""],["2019-08-21","Fehling Instruments GmbH & Co. KG",2,2,"","Gerald Fehling","fehling-instruments-gmbh-co-kg-479523-08212019","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 479523, dated October 13, 2015). Based on our evaluation, it appears that you have addressed the violation(s) contained in t",0,[],"","",""],["2019-08-20","Tecres S.p.A.",2,2,"","Giovanni Faccioli","tecres-spa-459252-08202019","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 459252, dated August 14, 2015). Based on our evaluation, it appears that your firm has addressed the violation(s) contained",0,[],"3002808402","",""],["2019-08-19","Haw Par Healthcare Limited",0,0,"","Mr. Wee Ee Lim","haw-par-healthcare-limited-578581-08192019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Haw Par Healthcare Limited at 2 Chia Ping Road, #09-03, Haw Par TIGER BALM Building, Singapore, from February 25 to March 1, 2019. This warning letter summarizes significan",0,[0,7,9,10,14,17,18],"3001432470","",""],["2019-08-15","Enprani Co., Ltd.",0,0,"","Mr. Kim Tae Hoon","enprani-co-ltd-580548-08152019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Enprani Co., Ltd at 88 Chukhang-Daero 296 Beon-Gil, Jung-Gu, Incheon, from March 11 to 15, 2019. This warning letter summarizes significant violations of current good manuf",0,[0,4,5,6,9,14,15,17,18,21],"3010822322","",""],["2019-08-13","Balamurali K. Ambati , M.D., Ph.D.",0,0,"","Balamurali K. Ambati, M.D., Ph.D., MBA","balamurali-k-ambati-md-phd-585585-08132019","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between March 25 and April 4, 2019. Julian C. Hanson, representing FDA, reviewed your conduct as",0,[],"3015173289","",""],["2019-08-13","Ningbo Pulisi Daily Chemical Products Co., Ltd",0,0,"","Mr. Wenjun Qian","ningbo-pulisi-daily-chemical-products-co-ltd-577795-08132019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Ningbo Pulisi Daily Chemical Products Co., Ltd. at Fangjia Road Xiaocao\u2019e Town, Yuyao City, Zhejiang Province, from February 25 to 28, 2019. This warning letter summarizes",0,[4,6,13,14,17,18],"3003727322","",""],["2019-08-08","Lantech Pharmaceuticals Limited",0,0,"","Mr. V. Prakash Reddy","lantech-pharmaceuticals-limited-580027-08082019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Lantech Pharmaceuticals Limited, FEI 3012390454, at Sy. No. 78, 79, 80, & 145, Chittivalasa, Pydibhimavaram, Ranastalam, Andra Pradesh, from March 6 to 15, 2019. This warni",0,[0,3,4,7,14,18],"3012390454","",""],["2019-08-02","Emcure Pharmaceuticals Limited",0,0,"","Mr. Satish Mehta","emcure-pharmaceuticals-limited-576961-08022019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Emcure Pharmaceuticals Limited at Plot No. P-1 & P-2, I.T.B.T. Park, Phase II, M.I.D.C., Hinjwadi, Pune, Maharashtra, from February 11 to 20, 2019. This warning letter summ",0,[1,2,7,8,18],"3005151215","",""],["2019-08-02","Molteno Ophthalmic Limited",2,2,"","Tess E.S. Molteno","molteno-ophthalmic-limited-450427-08022019","The Food and Drug Administration. (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter (CMS 450427, dated February 27, 2015). Based on our evaluation, it appears that you have addressed the violation(s) containe",0,[],"3001227772","",""],["2019-08-02","NingBo Huize Commodity Co., Ltd.",0,0,"","Mr. Wenxuan Han","ningbo-huize-commodity-co-ltd-581345-08022019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, NingBo Huize Commodity Co., Ltd., at 14 Lizhou Road, Yuyao, Zhejiang, from March 18 to 22, 2019. This warning letter summarizes significant violations of current good manuf",0,[0,3,4,6,7,14,15,17,18,21],"3012941723","",""],["2019-08-02","Orthosoft, Inc. dba Zimmer CAS",2,2,"","Louis-Philippe Amiot","orthosoft-inc-dba-zimmer-cas-496307-08022019","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 496307, dated May 27, 2016). Based on our evaluation, it appears that you have addressed the violation(s) contained in this",0,[],"3003714383","",""],["2019-07-31","Carolina Liquid Chemistries Corp",2,2,"","Mr. Philip Shugart","carolina-liquid-chemistries-corp-573596-07312019","During an inspection of your firm located in Brea, CA from November 5 to 9, 2018, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures and distributes Class I and II in-vitro diagnostic reagents. Under",0,[17,18,20],"3000215862","",""],["2019-07-29","PharmScript, LLC",0,0,"","Michael Segal","pharmscript-llc-535618-07292019","The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our warning letter [WL #17-NWJ-11; dated August 23, 2017]. Based on our evaluation, it appears that you have adequately addressed the viola",0,[],"3012837733","",""],["2019-07-22","Curaleaf, Inc",0,8,"","Joseph Lusardi","curaleaf-inc-579289-07222019","This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://curaleafhemp.com in April and June 2019 and has determined that you take orders there for the products \u201cCBD Lotion,\u201d \u201cCBD Pain-R",0,[16,17,18,19,21],"3014827595","",""],["2019-07-16","Indoco Remedies Limited",0,0,"","Mr. Suresh G. Kare","indoco-remedies-limited-575313-07162019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Indoco Remedies Limited (Plant I) at L-14 IDC Verna Industrial Road, Vasco Da Gama, Goa, from January 17 to 25, 2019. This warning letter summarizes significant violations",0,[0,4,6,7,14,15,18],"3006644152","",""],["2019-07-12","CTX Lifesciences Private Ltd.",0,0,"","Mr. Kanak Jariwala","ctx-lifesciences-private-ltd-577416-07122019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, CTX Lifesciences Private Ltd. at 251-252 Plot, Sachin Magdalla Highway, Surat, Gujarat, from February 11 - 16, 2019. This warning letter summarizes significant deviations f",0,[7,14,18],"3006254924","",""],["2019-07-11","American Sales Company Inc",0,0,"","Mr. James Godwin","american-sales-company-inc-582707-07112019","The United States Food and Drug Administration (FDA) has reviewed your firm\u2019s listing information provided for diphenhydramine hydrochloride and zinc acetate, NDC 41520-090. Our review revealed that the listing for this product includes inaccurate information.",0,[17],"3000215439","",""],["2019-07-11","Essential Pharmacy Compounding",0,0,"","Justin M. Kohll","essential-pharmacy-compounding-489638-07112019","",0,[],"3003718003","",""],["2019-07-08","San Diego Compounding Pharmacy",0,0,"","Jerome A. Greene","san-diego-compounding-pharmacy-520259-07082019","The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our warning letter [CMS# 520259, September 25, 2017]. We acknowledge that your firm no longer produces sterile drug products. Based on our",0,[],"3006072852","",""],["2019-07-02","N-Molecular Inc. d.b.a. SOFIE",0,0,"","Patrick W. Phelps","n-molecular-inc-dba-sofie-553833-07022019","The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our warning letter (CMS # 553833) dated September 24, 2018. Based on our evaluation, it appears that you have adequately addressed the viol",0,[],"3005693151","",""],["2019-07-01","I.T.S. GmbH",2,2,"","Wolfgang Auf","its-gmbh-422665-07012019","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 422665, dated June 30, 2014). Based on our evaluation, it appears that you have addressed the violations contained in this W",0,[],"3004369035","",""],["2019-07-01","Strides Pharma Science Limited",0,0,"","Mr. Arun Kumar","strides-pharma-science-limited-576722-07012019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Strides Pharma Science Limited at Unit-II, R. S. No.: 32, 33 & 34 PIMS Road Periyakalapet, Puducherry, from January 28 to February 5, 2019. This warning letter summarizes s",0,[0,7,14,15,18],"3012448465","",""],["2019-06-28","Hangzhou Facecare Cosmetics Co., Ltd.",0,0,"","John Wu","hangzhou-facecare-cosmetics-co-ltd-537146-06282019","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter: 320-18-09 dated November 17, 2017. Based on our evaluation, it appears that you have addressed the violations contained in t",0,[],"3008655176","",""],["2019-06-26","RX South DBA RX3 Compounding Pharmacy LLC",0,0,"","Christopher K. Currin, R.Ph.","rx-south-dba-rx3-compounding-pharmacy-llc-440735-06262019","The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our warning letter dated October 23, 2014. Based on our evaluation, it appears that you have adequately addressed the violations contained",0,[],"3008723337","",""],["2019-06-24","Abington Memorial Hospital, IRC",1,4,"","G. Chris Christensen III, DO","abington-memorial-hospital-irc-576854-06242019","This Warning Letter informs you of objectionable conditions observed during a Food and Drug Administration (FDA) inspection of the Abington Memorial Hospital Institutional Review Board (IRB) conducted between February 11, 2019 and February 15, 2019. The FDA in",0,[],"2523696","",""],["2019-06-24","AllerQuest LLC",0,0,"","Louis Mendelson, MD","allerquest-llc-578557-06242019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, AllerQuest LLC, FEI: 3006900385, at 10 Farmington Valley Drive, Suite 106, Plainville, Connecticut, from January 31 to March 1, 2019. This warning letter summarizes signifi",0,[1,2,7,8,14,18],"3006900385","",""],["2019-06-20","Aurobindo Pharma Limited",0,0,"","Mr. N. Govindarajan","aurobindo-pharma-limited-577033-06202019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Aurobindo Pharma Limited (APL), Unit XI at Sy. No. 61-66, IDA, Pydibhimavaram, Ranasthalam (Mandal), Srikakulam District, AP, from February 4 to 9, 2019. This warning lette",0,[7,14,18],"3004611182","",""],["2019-06-13","Fagron, Inc",0,0,"","Rafael Padilla","fagron-inc-545906-06132019","The Food and Drug Administration has completed evaluation of your firm\u2019s corrective actions in response to our Warning Letter [Case# 545906] dated August 29, 2018. Based on our evaluation, it appears that you have addressed the violation(s) contained in this W",0,[],"","",""],["2019-06-13","Michigan Medicine",0,0,"","Stanley S. Kent, R.Ph.","michigan-medicine-518396-06132019","The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our warning letter [Case #518396, September 28, 2017]. Based on our evaluation, it appears that you have adequately addressed the violation",0,[],"3003531601","",""],["2019-06-13","Morton Drug Company dba Morton LTC",0,0,"","Stephen C. Morton","morton-drug-company-dba-morton-ltc-496920-06132019","The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to warning letter #MIN 17-01 dated October 26, 2016. Based on our evaluation, it appears that you have adequately addressed the violations con",0,[],"3008927138","",""],["2019-06-13","Rxhomeo Private Limited",0,0,"","Mr. Shiv Shanker Asthana","rxhomeo-private-limited-575889-06132019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Rxhomeo Private Limited (FEI 3005269310) at Indradhanush, 4-1-424 to 426, Bank Street, Abids, Hyderabad, Telangana, from January 28 to February 1, 2019. This warning letter",0,[3,4,7,13,14,15,18],"3005269310","",""],["2019-06-11","Cali Botanicals, LLC",0,0,"","Mr. Justin Martinez","cali-botanicals-llc-575320-06112019","This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.calibotanicals.com in March 2019 and has determined that you take orders there for various kratom products, including but not limited to, \"",0,[16,17,19,21],"3015123330","",""],["2019-06-11","SynCardia Systems LLC",2,2,"","Don Webber","syncardia-systems-llc-537226-06112019","",0,[],"3003761017","",""],["2019-06-10","Xi'an Livingbond Nonwoven Products Corp., Ltd.",0,0,"","Mr. Yuhui Guo","xian-livingbond-nonwoven-products-corp-ltd-574591-06102019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Xi\u2019an Livingbond Nonwoven Products Corp., Ltd. , at 46, Jeyakgongdan 2-gil, Hyangnam-eup, No. 3 Standardized Plant, Xingyuan Road, Fengjing Ind Park, Hu District, Xian Shaa",0,[4,6,13,14,17,18],"3013558030","",""],["2019-06-04","Laser Dental Innovations",2,2,"","Howard A. Feinberg","laser-dental-innovations-546341-06042019","The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated February 27, 2018. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Fu",0,[],"3003610527","",""],["2019-06-04","Sovereign Pharmaceuticals, LLC",0,0,"","Paul D. Hafey","sovereign-pharmaceuticals-llc-303858-06042019","",0,[],"3003229412","",""],["2019-06-03","Curasan AG, Frankfurt Facility",2,2,"","Mr. Michael Schlenk","curasan-ag-frankfurt-facility-534581-06032019","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS #534581, dated August 23, 2017). Based on our evaluation, it appears that you have addressed the violations contained in this",0,[],"3004847139","",""],["2019-05-31","Glint Cosmetics Pvt Ltd",0,0,"","Mr. B. M. Chopra","glint-cosmetics-pvt-ltd-573468-05312019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Glint Cosmetics Pvt. Ltd. at C-216-218, TTC Industrial Area, MIDC Turbhe, Navi Mumbai, Maharashtra, from December 17 to 22, 2018. This warning letter summarizes significant",0,[0,3,6,14,16,17,18],"3009729392","",""],["2019-05-29","Vida International, Inc.",0,0,"","Mr. Ching Wen (Kevin) Wu","vida-international-inc-573082-05292019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility Vida International, Inc. at Number 263-2 Zhongshan North Road, Dayuan District, Taoyuan City, 33759, Taiwan, from December 10 to 13, 2018. This warning letter summarizes sig",0,[6,7,13,14,15,18],"3003220372","",""],["2019-05-24","INCELL Corporation LLC",0,0,"","Mary P. Moyer","incell-corporation-llc-491621-05242019","",0,[],"3004107906","",""],["2019-05-24","Inova Genomics Laboratory",2,2,"","Ramaswamy Iyer","inova-genomics-laboratory-577422-05242019","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 577422, dated April 4, 2019). Based on our evaluation, it appears that you have addressed the violation(s) contained in this",0,[],"3003793811","",""],["2019-05-24","TELEMED",2,2,"","Dmitry Novikov","telemed-540646-05242019","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter CMS 540646. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA",0,[],"3007994837","",""],["2019-05-20","Jessie Commodity Co., Ltd.",0,0,"","David Wei","jessie-commodity-co-ltd-576935-05202019","The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #1271, issued on April 18, 2019. Based on our evaluation, it appears that you have addressed the violations contained in this Warni",0,[],"3008456981","",""],["2019-05-16","KratomNC",0,0,"","Mike Davies","kratomnc-576964-05162019","This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the internet address http://kratomnc.com in May 2019 and has determined that your website provides a telephone number that customers can call to order various krato",0,[16,17,19,21],"3015179728","",""],["2019-05-16","Spectranetics Corporation",2,2,"","Christopher Barys","spectranetics-corporation-491979-05162019","The Food and Drug Administration has completed evaluation of your firm\u2019s corrective actions in response to our Warning Letter [DEN-16-08-WL dated May 23, 2016]. Based on our evaluation, it appears that you have addressed the violations contained in this Warnin",0,[],"3007284006","",""],["2019-05-13","21st Century Scientific Inc",2,2,"","Ronald E. Prior","21st-century-scientific-inc-566834-05132019","During an inspection of your firm located in Coeur d\u2019Alene, ID on September 10, 2018 through September 12, 2018, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Bounder powered wheelchairs. Und",0,[10,11,12,17,20],"1000125727","",""],["2019-05-13","Orchid Orthopedic Solutions, LLC",2,2,"","Jerry Jurkiewicz","orchid-orthopedic-solutions-llc-580112-05132019","The United States Food and Drug Administration (FDA) conducted an inspection of your firm\u2019s medical device operations, Orchid Orthopedic Solutions, LLC, located at 23149 Commerce Dr. Farmington Hills, MI, from February 4 through February 15, 2019. During the i",0,[2,4,9,18,20],"3011277306","",""],["2019-05-13","Orchid Orthopedic Solutions, LLC",2,2,"","Nathan A. Folkert","orchid-orthopedic-solutions-llc-580112-05132019-0","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS # 580112) issued on May 13, 2019, at CEP Bio-Coat/Orchid Orthopedic Solutions, LLC, located at 23149 Commerce Drive, Farmingto",0,[],"","",""],["2019-05-09","Rocky Mountain Pharmacy Inc.",0,0,"","Holly F. Graff Rotar","rocky-mountain-pharmacy-inc-574231-05092019","From March 6, 2018, to March 13, 2018, a U.S. Food and Drug Administration (FDA) investigator inspected your facility, Rocky Mountain Pharmacy, Inc., located at 25 N. Willson Ave., Suite C, Bozeman, MT 59715-3580. During the inspection, the investigator noted",0,[3,17,18,21],"3013935808","",""],["2019-05-08","Shenzhen Creative Industry Co., Ltd.",2,2,"","Wang Jia","shenzhen-creative-industry-co-ltd-484188-05082019","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter dated 01/15/2016 and the inspection conducted on 11/05-08/2018. Based on our evaluation, it appears that you have addressed the vio",0,[],"3006733253","",""],["2019-05-07","Petra Hygienic Systems Int Ltd",0,0,"","Mr. Sam Maduri","petra-hygienic-systems-int-ltd-572769-05072019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Petra Hygienic Systems International LLC at 86 Moyal Court, Concord, Ontario, from December 17 to 21, 2018. This warning letter summarizes significant violations of current",0,[3,7,13,14,18],"3002869527","",""],["2019-05-04","Centurion Laboratories Private Limited",0,0,"","Hemin Patel","centurion-laboratories-private-limited-571255-05042019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Centurion Laboratories Private Limited, FEI 3008342939, located at Plot P-2, Bio-Tech Park at Manjusar, Tal-Savli, GIDC, Manjusar, Gujarat, from October 22 to 26, 2018. Thi",0,[0,3,6,7,14,18],"3008342939","",""],["2019-05-03","Stanmore Implants Worldwide Ltd.",2,2,"","Michael Mainelli","stanmore-implants-worldwide-ltd-444402-05032019","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (Case #444402), issued on November 26, 2014. Based on our evaluation, it appears that you have addressed the violations contained i",0,[],"3004105610","",""],["2019-05-02","ABC Compounding Company Inc",0,0,"","Jon Craytor","abc-compounding-company-inc-576953-05022019","The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #1398, issued on April 18, 2019. Based on our evaluation, it appears that you have addressed the violations contained in this Warni",0,[],"3012553246","",""],["2019-05-01","Buderer Drug Company Inc",0,0,"","James W. Buderer","buderer-drug-company-inc-506509-05012019","The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our warning letter (CIN-16-506509-22), dated September 20, 2016. Based on our evaluation, it appears that you have adequately addressed the",0,[],"3005664940","",""],["2019-04-29","Apnea Sciences Corporation",2,2,"","James Fallon","apnea-sciences-corporation-392712-04292019","The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (WL #37-13), dated 05/09/2013. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Lett",0,[],"3009549393","",""],["2019-04-29","TSDR Pharmacy Inc. dba brandMD Skin Care",0,14,"","Samuel D. Raoof","tsdr-pharmacy-inc-dba-brandmd-skin-care-540960-04292019","The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s response to our warning letter dated November 9, 2017. We acknowledge that your California state-issued pharmacy license (PHY 50543) has been cancelled and that your facilit",0,[],"3009248035","",""],["2019-04-25","Pine Pharmacy and Home Care Products Center, Inc.",0,0,"","Alfonse Muto, Sr.","pine-pharmacy-and-home-care-products-center-inc-435704-04252019","The U.S. Food and Drug Administration (FDA) has completed an evaluation of (your/your firm\u2019s) corrective actions in response to our warning letter (ref: NYK-2015-24), dated February 13, 2015. Based on our evaluation, it appears that you have adequately address",0,[],"3010285019","",""],["2019-04-24","Stonegate Pharmacy LP",0,0,"","Rene F. Garza, PharmD","stonegate-pharmacy-lp-505526-04242019","",0,[],"3012038236","",""],["2019-04-23","Contacare Ophthalmics & Diagnostics",0,0,"","Mr. Jagrat N. Dave","contacare-ophthalmics-diagnostics-570360-04232019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Contacare Ophthalmics & Diagnostics at Block Number 310B, Dabhasa, Padra Taluka, Dist. Vadodara, Gujarat from October 25 to November 1, 2018. This warning letter summarizes",0,[1,2,3,7,14,16,17,18,21],"3006217304","",""],["2019-04-23","Laboratoires Clarins",0,0,"","Mr. Denis Martin","laboratoires-clarins-568157-04232019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Laboratoires Clarins at 5 rue Amp\u00e9re, Pontoise, from September 17 to 21, 2018. This warning letter summarizes significant violations of current good manufacturing practice",0,[3,4,7,14,18],"3002759467","",""],["2019-04-22","Pensacola Apothecary, Inc. DBA Everwell Specialty Pharmacy",0,0,"","Christopher M. Schulte","pensacola-apothecary-inc-dba-everwell-specialty-pharmacy-524550-04222019","",0,[],"3005630265","",""],["2019-04-18","ABC Compounding Company Inc",0,0,"","Kim Inman","abc-compounding-company-inc-576953-04182019","",0,[17],"3012553246","",""],["2019-04-18","Jessie Commodity Co., Ltd.",0,3,"","Wei Jianjian","jessie-commodity-co-ltd-576935-04182019","",0,[17],"3008456981","",""],["2019-04-12","RTI Surgical, Inc. dba RTI Biologics, Inc.",1,3,"","Mr. Camille Farhat","rti-surgical-inc-dba-rti-biologics-inc-525318-04122019","The Food and Drug Administration has completed an evaluation of your firm's actions in response to our Warning Letter [OBPO-1 18-01] dated, November 8, 2017, for adulteration and misbranding of a drug product. Based on our evaluation of your firm's manufacturi",0,[17,18],"3002719998","",""],["2019-04-04","Inova Genomics Laboratory",2,2,"","Ramaswamy Iyer, Ph.D.","inova-genomics-laboratory-577422-04042019","The Food and Drug Administration (FDA) has learned that your firm is marketing the MediMap ADHD, the MediMap Mind, the MediMap Plus, the MediMap Heart, and the MediMap Baby (collectively the MediMap tests) in the United States without marketing clearances or a",0,[17,18,20],"3003793811","",""],["2019-04-04","Luen Fook Medicine Sdn. Bhd.",0,0,"","Mr. Tham Chew Thor","luen-fook-medicine-sdn-bhd-572963-04042019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Luen Fook Medicine Sdn., Bhd., at Taman Perindustrian Sri Plentong, No 6, Jalan Sri Plentong 5, Masai, Johor, 81750 Malaysia, from December 10 to 14, 2018. This warning let",0,[3,4,9,14,16,18],"3001321832","",""],["2019-04-02","Civic Center Pharmacy Inc.",0,0,"","Tenille D. Davis","civic-center-pharmacy-inc-453724-04022019","The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our warning letter #32-15 dated August 20, 2015. Based on our evaluation, it appears that you have adequately addressed the violations cont",0,[],"3005144312","",""],["2019-03-21","B. Jain Pharmaceuticals Private Limited",0,0,"","Mr. Kuldeep Jain","b-jain-pharmaceuticals-private-limited-567957-03212019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, B. Jain Pharmaceuticals Pvt., Ltd, FEI 3010212308, located at E-41/F RIICO Industrial Area, Bhiwadi Rajasthan, from August 13, 2018 to August 29, 2018. This warning letter",0,[9,14,17,18],"3010212308","",""],["2019-03-18","Dong Yuan Technology Co., Ltd.",0,0,"","Mr. Buru Wang","dong-yuan-technology-co-ltd-568292-03182019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Dong Yuan Technology Co., Ltd. at No. 12 Volvo Road, Economic and Technical Development Zone Linyi, Shandong Province, from September 24 to 28, 2018. This warning letter su",0,[0,4,18],"3011780163","",""],["2019-03-18","Mentor Worldwide LLC & Acclarent",2,19,"","Alex Gorsky","mentor-worldwide-llc-acclarent-573520-03182019","The Food and Drug Administration (FDA) approved your device, MemoryShape, under Premarket Approval (PMA) Application, P060028, on June 14, 2013. In addition to the periodic reporting requirements, FDA ordered your firm to conduct a post-approval study (PAS) in",0,[20],"1000124389","",""],["2019-03-18","Sientra Inc",2,19,"","JoAnn Kuhne, MSN, RAC","sientra-inc-573436-03182019","The Food and Drug Administration (FDA) approved your device, Sientra Silicone Gel Breast Implants, under Premarket Approval (PMA) Application, P070004, on March 9, 2012. In addition to the periodic reporting requirements, FDA ordered your firm to conduct a Pos",0,[20],"3001628772","",""],["2019-03-15","Vilex in Tennessee, Inc",2,3,"","Silvia J. Southard","vilex-tennessee-inc-543749-03152019","The Food and Drug Administration has completed evaluation of your firm's corrective actions in response to our Warning Letter #543749, dated January 8, 2018. Based on our evaluation, it appears that you have addressed the violations contained in this Warning L",0,[],"1051526","",""],["2019-03-11","Maryland Specialty and Compounding Pharmacy, LLC (formerly Professional Arts",0,3,"","Simeon Georgiou","maryland-specialty-and-compounding-pharmacy-llc-formerly-professional-arts-518272-03112019","The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our warning letter (WL # 518272) dated April 3, 2017. We acknowledge that your firm no longer produces sterile drug products. Based on our",0,[],"3004514280","",""],["2019-03-11","Nutra Pharma",0,0,"","Rik J. Deitsch","nutra-pharma-563949-03112019","This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.Nyloxin.com, from which you take orders for your products \u201cNyloxin Oral Spray,\u201d \u201cNyloxin Topical Gel,\u201d \u201cNyloxin Topical Roll-On,\u201d \u201cNyloxin Topical Roll-On ES,\u201d",0,[16,17,18,19,21],"3019944255","",""],["2019-03-08","Aidaccess.org",0,0,"","","aidaccessorg-575658-03082019","",0,[16,17,18,21],"3014867993","",""],["2019-03-06","ARJ Infusion Services Inc",0,3,"","Mary L. Sackuvich","arj-infusion-services-inc-548673-03062019","The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our warning letter (ref: Case# 548673) dated April 2, 2018. Based on our evaluation, it appears that you have adequately addressed the viol",0,[],"3013452490","",""],["2019-03-06","Ignatius P. Godoy, M.D.",1,3,"","Ignatius P. Godoy, M.D.","ignatius-p-godoy-md-561662-03062019","The Food and Drug Administration completed an evaluation of your corrective actions in response to our Warning Letter CBER-19-01 dated October 1, 2018. Based on our evaluation, it appears that you addressed the violations contained in this Warning Letter. Futu",0,[],"3014133792","",""],["2019-03-06","Jubilant Generics Limited",0,0,"","Mr. Pramod Yadav","jubilant-generics-limited-569799-03062019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Jubilant Generics Limited at Roorkee \u2013 Dehradun Highway, Sikanderpur Bhainswal, Uttaranchal from July 30, 2018, to August 8, 2018. This warning letter summarizes significan",0,[7,14,18],"3006895982","",""],["2019-03-06","TEI Biosciences, Inc.",2,2,"","Peter Arduini","tei-biosciences-inc-573474-03062019","The United States Food and Drug Administration (FDA) conducted an inspection of your firm\u2019s medical device operations, TEI Biosciences, Inc., an Integra LifeSciences Company, located at 7 Elkins Street, Boston, MA, from October 9 through November 2, 2018. Duri",0,[2,3,4,9,18,20],"3004170064","",""],["2019-03-04","Hospira Healthcare India Pvt. Ltd.",0,0,"","Mr. Albert Bourla","hospira-healthcare-india-pvt-ltd-557890-03042019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Hospira Healthcare India Pvt. Ltd., at Plots B3, B4, B5 (pt); B6 (pt); B11-B18 and B21-B23, SIPCOT Industrial Park, Irungattukottai, Sriperumbudur, Kancheepuram District, T",0,[0,1,2,6,7,8,10,18],"3008386908","",""],["2019-02-28","Anicare Pharmaceuticals Pvt Ltd.",0,0,"","Mr. Hitesh Mehta","anicare-pharmaceuticals-pvt-ltd-569251-02282019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Anicare Pharmaceutical Pvt. Ltd., at Plot No. A 143/5&6, TTC Industrial Area, Khairne Village, Thane-Belapur Rd., Navi Mumbai, from July 30 to August 3, 2018. This warning",0,[3,4,6,14,16,17,18],"3007450508","",""],["2019-02-26","CanaRx Services Inc",0,0,"","Mr. Gregory Anthony Howard","canarx-services-inc-554740-02262019","",0,[16,17,18,21],"3004133316","",""],["2019-02-26","Millers of Wyckoff, Inc.",0,3,"","David M. Miller, R.Ph","millers-wyckoff-inc-484793-02262019","The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our warning letter # 16-NWJ-09, dated June 7, 2016. Based on our evaluation, it appears that you have adequately addressed the violations c",0,[],"3004600183","",""],["2019-02-25","Laboratorios Quantium LLC",0,0,"","Jose Luis Garcia","laboratorios-quantium-llc-569146-02252019","",0,[3,4,6,7,13,14,16,18],"3008529478","",""],["2019-02-25","Liberty Drug & Surgical",0,3,"","Alan Brown","liberty-drug-surgical-485027-02252019","The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our warning letter # 16-NWJ-05 dated March 14, 2016. We acknowledge that your firm no longer produces sterile drug products and in the abse",0,[],"3002127548","",""],["2019-02-25","A-S Medication Solutions LLC.",0,3,"","Walter Hoff","s-medication-solutions-llc-522197-02252019","",0,[],"1450743","",""],["2019-02-25","Vilvet Pharmaceutical",0,0,"","Damaris McWilliams","vilvet-pharmaceutical-566336-02252019","",0,[6,14,15,17,18],"3013511339","",""],["2019-02-22","Total Thermal Imaging, Inc.",2,2,"","Linda Hayes","total-thermal-imaging-inc-567742-02222019","During an inspection of your firm, Total Thermal Imaging, Inc. (TTI), located in La Mesa, CA on July 3, 2018 through August 2, 2018, investigators from the United States Food and Drug Administration (FDA) determined that TTI manufactures and markets the Thermo",0,[9,10,11,12,13,17,18,20],"3013987098","",""],["2019-02-13","Proandre SL",0,0,"","Mr. Manuel Suarez Marin","proandre-sl-567234-02132019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Proandre SL at Calle Condestable De Portugal 43-45, Granollers, Barcelona, from June 11 to 14, 2018. This warning letter summarizes significant violations of current good m",0,[0,6,14,15,17,18],"3006763819","",""],["2019-02-12","American Preclinical Services",2,10,"","Michael L. Conforti, D.V.M., M.S., M.B.A","american-preclinical-services-562382-02122019","This Warning Letter is to inform you of objectionable conditions observed during the Food and Drug Administration (FDA) inspection of your site from March 19, 2018 to April 13, 2018, by investigators from the FDA\u2019s Office of Bioresearch Monitoring Operations (",0,[9,20],"3005802236","",""],["2019-02-11","Becton Dickinson Medical Systems",2,3,"","Vincent Forlenza","becton-dickinson-medical-systems-563754-02112019","The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS # 563754 dated September 14, 2018. Based on our evaluation, it appears that you have addressed the violation(s) contained in th",0,[],"1000299851","",""],["2019-02-06","Datascope Corp.",2,2,"","Mr. Philip Freed","datascope-corp-573566-02062019","The United States Food and Drug Administration (FDA) conducted an inspection of your firm\u2019s medical device operations at 1300 Macarthur Blvd., Mahwah, NJ, from July 30, 2018 through October 3, 2018. During the inspection, FDA investigators determined that your",0,[9,12,18,20],"3001418283","",""],["2019-02-06","The Wellness Center Pharmacy, Inc., dba Designer Drugs",0,0,"","Randal J. Davis","wellness-center-pharmacy-inc-dba-designer-drugs-496523-02062019","The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our warning letter #2016-NOL-11 dated August 5, 2016. Based on our evaluation, it appears that you have adequately addressed the violations",0,[],"3004578635","",""],["2019-01-30","Phi Sciences",0,0,"","Dr. Patrick Flanagan","phi-sciences-566043-01302019","From August 10-18, 2018, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 271 S. Airpark Road, Cottonwood, Arizona. Based on the inspectional findings, a review of the product labels collected during the inspectio",0,[16,17,18,19,21],"","",""],["2019-01-29","Hangzhou SunKing Nonwovens Co., Ltd.",0,3,"","Mr. Ma Xing Fa","hangzhou-sunking-nonwovens-co-ltd-568546-01292019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility Hangzhou Sunking Nonwovens Co., Ltd., at No. 888 Chongchao Rd., Chongxian Industrial Area, Hangzhou, Zhejiang, from August 7 to 9, 2018. This warning letter summarizes signi",0,[4,6,9,13,14,18],"3010166722","",""],["2019-01-29","Vipor Chemicals Private Ltd.",0,0,"","Mr. Popatlal S. Patel","vipor-chemicals-private-ltd-555392-01292019","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Vipor Chemicals Private Ltd. at 218 GIDC Makarpura, Vadodara, Gujarat, from February 21 to 24, 2018. This warning letter summarizes significant deviations from current good",0,[3,7,14,18],"3003090962","",""],["2019-01-11","Dongying Tiandong Pharmaceutical Co Ltd",0,3,"","Dr. Lei Dong","dongying-tiandong-pharmaceutical-co-ltd-506849-01112019","The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter: 320-17-06 dated November 10, 2016. Based on our evaluation, it appears that you have addressed the deviations contained in t",0,[],"3004395180","",""],["2019-01-10","Vitalab Pharmacy, Inc.",0,3,"","Paul Vasiliauskas","vitalab-pharmacy-inc-570563-01102019","From March 26, 2018, to April 4, 2018, a U.S. Food and Drug Administration (FDA) investigator inspected your facility, Vitalab Pharmacy, Inc., dba Vasco Rx, located at 4045 E. Bell Road, Suite 163, Phoenix, AZ 85032. During the inspection, the investigator not",0,[1,18],"3007816026","",""],["2019-01-08","Lymol Medical Corp",0,0,"","Kim Abrano","lymol-medical-corp-570153-01082019","The U.S. Food and Drug Administration (FDA) has determined that Lymol Medical Corporation (\u201cLymol\u201d) failed to comply with the milestone date in the timetable for completion of a postmarketing requirement (PMR) for Sterile Talc Powder\u00ae under New Drug Applicatio",0,[17],"","",""],["2018-12-31","Merete Medical GmbH",2,2,"","Alexia Anapliotis","merete-medical-gmbh-571091-12312018","During an inspection of your firm located in Alt-Lankwitz, Berlin, Germany, on August 27, 2018 through August 29, 2018, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Intrablock Bioball Hip Syst",0,[1,2,4,6,8,9,10,11,12,17,18],"3002949614","",""],["2018-12-18","Fallon Wellness Pharmacy, L.L.C.",0,0,"","Peter L. Fallon","fallon-wellness-pharmacy-llc-485889-12182018","The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our warning letter, WL # NYK-2016-23, dated February 1, 2016. We acknowledge that your firm no longer produces sterile drug products. Based",0,[],"3007942369","",""],["2018-12-17","World Organic Corp.",2,3,"","Paul J. Licata","world-organic-corp-441366-12172018","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter #32-16, issued June 17, 2016. Based on our evaluation, it appears that you have addressed the violations contained in this Warning",0,[],"1526809","",""],["2018-12-14","Hangzhou Guoguang Touring Commodity Co.,Ltd.",0,0,"","Mr. Qicai Fu","hangzhou-guoguang-touring-commodity-coltd-564286-12142018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Hangzhou Guoguang Touring Commodity Co., Ltd. at No. 8 Yushun Road, Jingshan Town, Yuhang District, Hangzhou, Zhejiang, from April 17 to 20, 2018. This warning letter summa",0,[3,6,7,14,18],"3008785460","",""],["2018-12-14","Longbow First Aid Products Manufactory",0,0,"","Mr. Zhiyuan Dong","longbow-first-aid-products-manufactory-559326-12142018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Longbow First Aid Products Manufactory at 2/F, A3 Building, Hantian Industrial Park, Guiping Road, Guicheng, Foshan, from April 16 to 20, 2018. This warning letter summariz",0,[1,2,6,13,14,18],"3006102089","",""],["2018-12-13","Samson Pharmaceuticals, Inc",0,3,"","Jay G. Kassir","samson-pharmaceuticals-inc-554307-12132018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Samson Pharmaceuticals, Inc., at 2027 Leo Avenue, Commerce, California from January 24 to February 9, 2018. This warning letter summarizes significant violations of current",0,[1,2,5,6,8,13,18],"3005644727","",""],["2018-12-13","Soleo",0,0,"","Mr. Ji Hyun Min","soleo-567046-12132018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Soleo at 24 Sandan-Ro, Pyeongtaek-Si, Gyeonggi-do, from August 6 to 9, 2018. This warning letter summarizes significant violations of current good manufacturing practice (C",0,[4,5,6,7,13,16,18],"3009699696","",""],["2018-12-11","University Rx Specialists Inc",0,0,"","Joseph Grasela, RPh","university-rx-specialists-inc-495985-12112018","The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our warning letter, WL # 51-16, dated September 28, 2016. We acknowledge that your firm receives valid prescriptions for individually-ident",0,[],"3004599113","",""],["2018-12-03","Skylark CMC Pvt. Ltd.",0,3,"","Tushar Patel","skylark-cmc-pvt-ltd-567229-12032018","On June 25, 2018, the U.S. Food and Drug Administration (FDA) arrived at your drug manufacturing facility, Skylark CMC Pvt. Ltd. near Electric Sub Station, Odhav Road, Ahmedabad, Gujarat, to conduct an inspection. Our investigator documented that your firm lim",0,[18],"3003658163","",""],["2018-12-03","University of Miami Reproductive and Fertility Center",1,4,"","George Attia, MD","university-miami-reproductive-and-fertility-center-568208-12032018","The United States Food and Drug Administration (FDA) conducted an inspection of your firm, University of Miami Reproductive and Fertility Center, located at 1400 NW 12th Avenue, Suite 5, Miami, Florida, from July 10, 2018 thru July 12, 2018. During the inspect",0,[],"3005089639","",""],["2018-12-03","Zyno Medical, LLC",2,3,"","Chaoyoung Lee, Ph.D.","zyno-medical-llc-507058-12032018","The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter dated December 5, 2016. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warnin",0,[],"3006575795","",""],["2018-11-30","Cao Medical Equipment Co., Ltd.",0,0,"","Dianlong Cao","cao-medical-equipment-co-ltd-568152-11302018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Cao Medical Equipment Co., Ltd. at Number 19 Baihe Road, Langfang Industrial Zone, Langfang, Hebei, from July 16 to 20, 2018. This warning letter summarizes significant vio",0,[4,18],"3004475754","",""],["2018-11-30","United Exchange Corporation",0,3,"","Ellen Chang","united-exchange-corporation-565551-11302018","The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #1285, issued on October 29, 2018. Based on our evaluation, it appears that you have addressed the violations contained in this War",0,[],"3006266338","",""],["2018-11-29","Genetech, Inc.",1,4,"","Edwin N. Pinos","genetech-inc-561808-11292018","",0,[1,2,8,14],"3013306140","",""],["2018-11-29","Zhejiang Huahai Pharmaceutical",0,0,"","Mr. Jun Du","zhejiang-huahai-pharmaceutical-566685-11292018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Zhejiang Huahai Pharmaceutical Co., Ltd., located at Coastal Industrial Zone, Chuannan No. 1 Branch No. 9, Donghai Fifth Avenue, Linhai, Taizhou Zhejiang, from July 23 to A",0,[3,7,10,14,18],"3003885745","",""],["2018-11-28","Barox Co., Ltd.",0,0,"","Mr. Hak-Ki Kim","barox-co-ltd-565314-11282018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Barox Co., Ltd. at Number 706, HallaSigma, 545, Dunchon-Daero, Jungwon-gu, Gyeonggi-do, Seongnam, from May 17 to 18, 2018. This warning letter summarizes significant violat",0,[14,18],"3010166805","",""],["2018-11-28","Organ Recovery Systems, Inc.",2,3,"","David Kravitz","organ-recovery-systems-inc-519572-11282018","The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CHI-07-17 dated April 20, 2017. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warn",0,[],"3004068499","",""],["2018-11-27","Hangzhou Zhongbo Industrial Co., Ltd.",0,0,"","Mr. Guokang Li","hangzhou-zhongbo-industrial-co-ltd-562839-11272018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Hangzhou Zhongbo Industrial Co., Ltd. at Yuhang District, Changle Industrial Zone, Hangzhou, Zhejiang, from April 23 to 27, 2018. This warning letter summarizes significant",0,[6,13,14,18],"3008229416","",""],["2018-11-16","Faro Ted Owiesy",0,3,"","Faro Ted Owiesy, M.D.","faro-ted-owiesy-564421-11162018","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between June 22 and June 27, 2018. Ms. Denise L. Burosh, representing FDA, reviewed your conduct",0,[],"3014376767","",""],["2018-11-09","Mylan Pharmaceuticals, Inc.",0,0,"","Heather Bresch","mylan-pharmaceuticals-inc-557903-11092018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Mylan Pharmaceuticals, Inc. at 781 Chestnut Ridge, Morgantown, West Virginia, from March 19, 2018, to April 12, 2018. This warning letter summarizes significant violations",0,[3,4,6,7,14,15,18],"1110315","",""],["2018-11-07","The Compounding Pharmacy of America",0,3,"","Victor A. Poteet, PharmD.","compounding-pharmacy-america-476703-11072018","",0,[],"3011504027","",""],["2018-11-06","Caliber Imaging & Diagnostics, Inc.",2,2,"","L. Michael Hone","caliber-imaging-diagnostics-inc-431658-11062018","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS# 431658) dated January 8, 2015. Based on our evaluation, it appears that your firm has addressed the violations contained in t",0,[],"3010623603","",""],["2018-10-30","Colon Care Products of PA, LLC",2,2,"","Arleen Ehritz","colon-care-products-pa-llc-460342-10302018","The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS #460342 dated May 28, 2015. Based on our evaluation, it appears that you have addressed FDA concerns regarding claims in",0,[],"3009129500","",""],["2018-10-29","Netcos Co., Ltd.",0,0,"","Bae Tae-Jong","netcos-co-ltd-565521-10292018","The United States Food and Drug Administration (FDA) has reviewed your firm\u2019s listing information provided for P8 Tone - Up and Brightening Creamex, NDC 71738-0007. Our review revealed that the listing for this product includes inaccurate information. You have",0,[17],"3011677555","",""],["2018-10-29","United Exchange Corporation",0,0,"","Ellen Chang","united-exchange-corporation-565551-10292018","The United States Food and Drug Administration (FDA) has reviewed your firm\u2019s listing information provided for (b)(4) . Our review revealed that the listing for this product includes inaccurate information. You have failed to address this listing deficiency de",0,[17],"3006266338","",""],["2018-10-26","Greenpark Compounding Pharmacy",0,0,"","Kenneth L. Hughes","greenpark-compounding-pharmacy-566233-10262018","",0,[1,2,8,18],"3009712882","",""],["2018-10-25","INCYTO CO., LTD.",2,2,"","Shane Cho","incyto-co-ltd-497916-10252018","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter [CMS#497916] dated September 8, 2016. Based on our evaluation, it appears that you have addressed the violations contained in this",0,[],"3010402713","",""],["2018-10-19","GS Medical Packaging Inc.",2,3,"","John Sherlock","gs-medical-packaging-inc-395298-10192018","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective and preventive actions in response to our Warning Letter (CMS# 395298) dated June 12, 2013. Based on our evaluation, it appears that your firm has addressed the violat",0,[9],"3003067378","",""],["2018-10-17","Ocular Therapeutix Inc.",2,2,"","Antony Mattessich","ocular-therapeutix-inc-564663-10172018","The Food and Drug Administration (FDA) approved your device, ReSure Sealant, under Premarket Approval (PMA) Application, P130004 on January 8, 2014. In addition to the periodic reporting requirements, FDA ordered your firm to conduct a post-approval study (PAS",0,[17,20],"3008477155","",""],["2018-10-16","International Medsurg Connection, Inc.",2,3,"","Omi Bhati","international-medsurg-connection-inc-511426-10162018","The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CHI-09-118 dated May 08, 2017. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warni",0,[],"3000210101","",""],["2018-10-15","CAO Group, Inc.",2,2,"","Densen B. Cao, Ph.D.","cao-group-inc-559299-10152018","This Warning Letter is to inform you of objectionable conditions observed during the Food and Drug Administration (FDA) inspection conducted at CAO Group, Inc., from May 1, 2018, to May 7, 2018, by investigators from the FDA\u2019s Office of Bioresearch Monitoring",0,[20],"3003258642","",""],["2018-10-15","John Meadors",2,2,"","John O. Meadors","john-meadors-559611-10152018","This Warning Letter is to inform you of objectionable conditions observed during the Food and Drug Administration (FDA) inspection conducted at your clinical site from April 30, 2018, to May 7, 2018, by investigators from the FDA\u2019s Office of Bioresearch Monito",0,[20],"3009093259","",""],["2018-10-09","IceRx",0,0,"","","icerx-1111111-10092018","",0,[16,17,21],"","",""],["2018-10-09","Western Enterprises/Scott Fetzer Company",2,3,"","Andrew Cheshire","western-enterprisesscott-fetzer-company-441366-10092018","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter CIN 15-441366-03, dated October 10, 2014. Based on our evaluation, it appears that you have addressed the violations containe",0,[],"1526809","",""],["2018-10-03","Hanlim Pharm Co., Ltd.",0,0,"","Mr. Jung Jin Kim","hanlim-pharm-co-ltd-553021-10032018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Hanlim Pharm Co., located at 2-27 Yeongmun-ro, Yonginsi Ceoin-gu, Gyeonggi-do, from January 29 to February 6, 2018. This warning letter summarizes significant violations of",0,[0,1,2,8,18],"3004886113","",""],["2018-10-02","Boule Medical AB",2,2,"","Mr. Fredrik O. Dalborg","boule-medical-ab-559614-10022018","During an inspection of your firm located in Stockholm, Sweden on May 7, 2018 through May 11, 2018, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures various Class II medical devices comprising the",0,[9,10,11,13,17,18],"3004008703","",""],["2018-10-01","Ignatius P. Godoy, M.D.",1,4,"","Ignatius P. Godoy, M.D.","ignatius-p-godoy-md-561662-10012018","This Warning Letter informs you of objectionable conditions observed during a Food and Drug Administration (FDA) inspection conducted between May 29, 2018, and June 8, 2018. An FDA investigator met with you during the inspection to review your conduct as a cli",0,[0,9],"3014133792","",""],["2018-09-24","N-Molecular Inc. d.b.a. SOFIE",0,0,"","Patrick W. Phelps","n-molecular-inc-dba-sofie-553833-09242018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, N-Molecular Inc. (d.b.a. SOFIE) at 11 Rogers Rd, Suite 6, Haverhill, Massachusetts, from February 12, 2018 to February 28, 2018. This warning letter summarizes significant",0,[1,2,8,18],"3005693151","",""],["2018-09-21","Cardiomed Supplies, Inc.",2,2,"","Mr. Christian G. Dub\u00e9","cardiomed-supplies-inc-564967-09212018","During an inspection of your firm located in Lindsay, Ontario, Canada on May 28, 2018 through May 31, 2018, an investigatorfrom the United States Food and Drug Administration (FDA) determined that your firm manufactures Phlebotomy Bag with Valve and Dual Float",0,[2,9,10,12,18,20],"3005612924","",""],["2018-09-17","Celltrion Inc.",0,0,"","Woo Sung Kee","celltrion-inc-534262-09172018","",0,[],"3005241015","",""],["2018-09-14","Euro Diagnostica AB",2,2,"","Ronald E. Long","euro-diagnostica-ab-524316-09142018","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter [CMS#524316] dated September 20, 2017. Based on our evaluation, it appears that you have addressed the violation(s) contained in th",0,[],"3007610287","",""],["2018-09-10","Wilson Medicine Company",0,22,"","Mr. Vineet Thakkar","wilson-medicine-company-557206-09102018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Wilson Medicine Company at Plot 24, S 361-364 Nandore, Palghar East, Maharashtra from February 26 to March 1, 2018. This warning letter summarizes significant violations of",0,[3,4,5,7,18],"3004974700","",""],["2018-09-05","Jabones Y Productos Especializados SA de CV",0,3,"","Mr. Adrian Lopez Sepulveda","jabones-y-productos-especializados-sa-de-cv-558088-09052018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Jabones Y Productos Especializados SA de CV at Cernicalo 155, Col. La Aurora, Guadalajara, Jalisco, from March 20 to 23, 2018. This warning letter summarizes significant vi",0,[4,6,7,10,13,14,15,18],"3007808836","",""],["2018-09-05","Leventon S. A. U.",2,2,"","Francesc Cuxart","leventon-s-u-560534-09052018","During an inspection of your firm located in Barcelona, Spain, on March 19, 2018, through March 22, 2018, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Dosi Flow elastomeric infusion pump and D",0,[11,12,17,18,20],"3002807471","",""],["2018-09-04","Chillin Mix Kratom",0,3,"","","chillin-mix-kratom-559280-09042018","This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.chillinmixkratom.com in July 2018 and has determined that you take orders there for various kratom products, including but not limited to,",0,[16,17,19,21],"3014606410","",""],["2018-09-04","Cook Inc.",2,2,"","Derek Voskuil","cook-inc-438190-09042018","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter, 2014-DET-16 (CMS Case 438190), issued on September 16, 2014. Based on our evaluation, it appears that you have addressed the viola",0,[],"1820334","",""],["2018-09-04","Lernapharm (Loris) Inc.",0,3,"","Mr. Razmik Margoosian","lernapharm-loris-inc-552525-09042018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Lernapharm (Loris) Inc. at 2323 Halpern St., Saint-Laurent, Montreal, from December 4 to 12, 2017. This warning letter summarizes significant violations of current good man",0,[1,2,4,6,7,8,10,14,18],"3004158845","",""],["2018-09-04","Mitra Distributing Inc.",0,3,"","Christopher Marion","mitra-distributing-inc-562402-09042018","This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.kratomwholesale.us in August 2018 and has determined that you take orders there for various kratom products, including but not limited to,",0,[16,17,19,21],"3014654355","",""],["2018-08-27","Longood Medicine (Beijing) Co Ltd",0,3,"","Mr. Shenglin Gao","longood-medicine-beijing-co-ltd-545459-08272018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Longood Medicine (Beijing) Co., Ltd. at No. 13, Yunteng Road, Beijing, from September 25 to 29, 2017. This warning letter summarizes significant violations of current good",0,[2,4,14,16,18],"3011090864","",""],["2018-08-21","Les Emballages Facoteck Inc",0,0,"","Mr. Martin Fortin","les-emballages-facoteck-inc-547755-08212018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Les Emballages Facoteck Inc. at 35 Victoria West, Scotstown, Quebec, from November 27 to December 1, 2017. This warning letter summarizes significant violations of current",0,[3,4,6,7,14,15,17,18,21],"3002955163","",""],["2018-08-21","Nomax Inc",2,2,"","Charles L. Voellinger","nomax-inc-512566-08212018","The Food and Drug Administration has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter (CMS Case: 512566), dated December 15, 2016. Based on our evaluation, it appears that you have addressed the violation(s) contained",0,[],"1937310","",""],["2018-08-16","CoinRx",0,3,"","","coinrx-08162018","",0,[16,17,21],"","",""],["2018-08-16","MedInc.biz",0,3,"","","medincbiz-08162018","",0,[16,17,21],"","",""],["2018-08-16","PharmacyAffiliates.org",0,3,"","","pharmacyaffiliatesorg-08162018","",0,[16,17,21],"","",""],["2018-08-16","PharmaMedics",0,3,"","","pharmamedics-08162018","",0,[16,17,21],"","",""],["2018-08-09","Apotex Research Private Limited",0,3,"","Dr. Ravinder Kumar","apotex-research-private-limited-547439-08092018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Apotex Research Private Limited at Plot 1 & 2, Bommasandra Industrial Area, 4 th Phase, Jigani Link Road, Bangalore, from November 6 to 17, 2017. This warning letter summar",0,[4,7,14,18],"3006076314","",""],["2018-08-01","Bill Beauty and Health Products Ltd.",0,3,"","Mr. Kenneth So","bill-beauty-and-health-products-ltd-555603-08012018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Bill Beauty and Health Products Ltd. at 120 Silver Star Blvd, Scarborough, Ontario, from March 12\u201316, 2018. This warning letter summarizes significant violations of current",0,[4,18],"3006695142","",""],["2018-07-31","Hangzhou Karic Commodities Co., Ltd.",0,3,"","Mr. Kaimin Bian","hangzhou-karic-commodities-co-ltd-556676-07312018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Hangzhou Karic Commodities Co., Ltd., at No. 2 Fifth Avenue, West Lake Science and Economic Zone, Hangzhou, from March 26 to 29, 2018. This warning letter summarizes signif",0,[4,18],"3006528506","",""],["2018-07-27","JT Cosmetics & Chemicals Pvt Ltd.",0,3,"","Mr. Chirag Arora","jt-cosmetics-chemicals-pvt-ltd-554478-07272018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, JT Cosmetics & Chemicals Pvt. Ltd. at 53 Kalol GIDC Estate, Panchmahal District, Gujarat, from February 26 to 28, 2018. This warning letter summarizes significant violation",0,[0,13,14,15,16,17,18],"3011783104","",""],["2018-07-26","Yicheng Goto Pharmaceuticals Co., Ltd",0,3,"","Mr. Michael Zou","yicheng-goto-pharmaceuticals-co-ltd-542678-07262018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Yicheng Goto Pharmaceuticals Co., Ltd. at Group 1 Gaokeng, Xiaohe Town, Yicheng City, Hubei Province, from September 11 to 14, 2017. This warning letter summarizes signific",0,[3,4,5,6,7,18],"3004459466","",""],["2018-07-24","Les Produits Chimiques B.G.R., Inc.",0,3,"","Mr. Sylvain Chevrier","les-produits-chimiques-bgr-inc-542247-07242018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Les Produits Chimiques B.G.R., Inc. at 600 Avenue Delmar, Pointe-Claire, Quebec, from September 25 to 27, 2017. This warning letter summarizes significant deviations from c",0,[0,3,6,14,18],"3000287309","",""],["2018-07-17","Yuki Gosei Kogyo Co., Ltd.",0,3,"","Mr. Masaru Matsui","yuki-gosei-kogyo-co-ltd-547871-07172018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Yuki Gosei Kogyo Co., Ltd. at Ochiai 788, Joban Nishigo-machi, Jobannishigo-Machi Iwaki, Fukushima, from November 13 to 17, 2017. This warning letter summarizes significant",0,[0,5,6,7,14,15,18],"3002808534","",""],["2018-07-05","Claris Injectables Limited",0,3,"","Amish Vyas","claris-injectables-limited-543187-07052018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Claris Injectables Ltd. at Ahmedabad, from July 27, 2017 to August 4, 2017. This warning letter summarizes significant violations of current good manufacturing practice (CG",0,[0,2,5,7,18],"3004610460","",""],["2018-07-02","Gaeltec Devices LTD",2,2,"","Derek L. Apps","gaeltec-devices-ltd-554344-07022018","During an inspection of your firm located in Dunvegan, United Kingdom on December 4, 2017, through December 7, 2017, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Catheter Tip Pressure Transduc",0,[2,4,9,10,11,17,18,20],"3008727541","",""],["2018-06-27","Zhuhai United Laboratories Co. Ltd.",0,3,"","Ms. Shirley Cai","zhuhai-united-laboratories-co-ltd-542230-06272018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Zhuhai United Laboratories Co., Ltd., at No. 2428 Anji Road, Sanzao Town, Jinwan District, Zhuhai, from September 11 to 15, 2017. This warning letter summarizes significant",0,[0,1,5,7,8,14,18],"3006531950","",""],["2018-06-26","Foshan Jinxiong Technology Co., Ltd.",0,3,"","Mr. Eric Qiu","foshan-jinxiong-technology-co-ltd-544173-06262018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Foshan Jinxiong Technology Co., Ltd. at Foshan City, Guangdong Province from August 15\u201318, 2017. This warning letter summarizes significant violations of current good manuf",0,[6,7,13,18],"3010387028","",""],["2018-06-22","Sichuan Friendly Pharmaceutical Co., Ltd.",0,3,"","Mr. Shenyou Gong","sichuan-friendly-pharmaceutical-co-ltd-546990-06222018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Sichuan Friendly Pharmaceutical Co., Ltd. at No. 680 Hongpai Road, Neijiang, Sichuan, from October 23 to 27, 2017. This warning letter summarizes significant deviations fro",0,[3,5,6,7,14,18],"3012903349","",""],["2018-06-12","Ami Cosmetics Co., Ltd.",0,3,"","Kyung Rok Lee","ami-cosmetics-co-ltd-546066-06122018","The United States Food and Drug Administration (FDA) has reviewed your firm\u2019s listing information provided for PureHeals Centella 70 Toning Swab, NDC 59535-0268, and found that this information is inaccurate. You have failed to address the listing deficiencies",0,[17,21],"3009953352","",""],["2018-06-12","Henan Lihua Pharmaceutical Co., Ltd.",0,3,"","Mr. Liu Dongxue","henan-lihua-pharmaceutical-co-ltd-548089-06122018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facilities, Henan Lihua Pharmaceutical Co. Ltd. at Middle of Huanghe Street, Anyang, Henan, and at Qilidian North Part of Antang Road, Longan District, Anyang, Henan, from December 1",0,[0,6,14,18],"3001164052","",""],["2018-06-08","BR SAS",0,3,"","Mr. Pierre-Louis Delapalme","br-sas-542617-06082018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Biologique Recherche (B.R.) SAS at 28 rue de la Procession, Suresnes, from September 18 to 22, 2017. This warning letter summarizes significant violations of current good m",0,[2,4,6,7,13,14,15,18],"1000373305","",""],["2018-06-07","US Vascular LLC",2,2,"","Galen T. Spooner","us-vascular-llc-554761-06072018","The United States Food and Drug Administration (FDA) conducted an inspection of your firm\u2019s medical device operations at 15246 NW Greenbrier Pkwy, Beaverton, OR from March 26 \u2013 30, 2018. During the inspection, an FDA investigator determined that your firm is a",0,[9,10,12,13,18],"3010089756","",""],["2018-06-06","M Dialysis AB",2,2,"","Olof Nord","m-dialysis-ab-554169-06062018","During an inspection of your firm located in Stockholm, Sweden on November 6 through November 9, 2017, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the ISCUS Flex system. Under section 201(h) of",0,[2,4,9,13,18,20],"3003733874","",""],["2018-05-31","Taiwan Biotech Co., LTD.",0,3,"","Dr. George Ko","taiwan-biotech-co-ltd-542530-05312018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Taiwan Biotech Company, Ltd at 22, Chieh-Shou Road, Taoyuan District, Taoyuan City, from September 1 to 11, 2017. This warning letter summarizes significant violations of c",0,[0,1,6,8,14,18],"3003598505","",""],["2018-05-29","AnonShop",0,3,"","","anonshop-05292018","",0,[16,17,21],"","",""],["2018-05-29","Eassybuyonline",0,3,"","","eassybuyonline-05292018","",0,[16,17,21],"","",""],["2018-05-29","Instabill ECS\u2010Rx",0,3,"","","instabill-ecs-rx-05292018","",0,[16,17,21],"","",""],["2018-05-29","Medstore.biz",0,3,"","","medstorebiz-05292018","",0,[16,17,21],"","",""],["2018-05-29","One Stop Pharma",0,3,"","","one-stop-pharma-05292018","",0,[16,17,21],"","",""],["2018-05-29","RemedyMart",0,3,"","","remedymart-05292018","",0,[16,17,21],"","",""],["2018-05-29","RxCash.Biz",0,3,"","","rxcashbiz-05292018","",0,[16,17,21],"","",""],["2018-05-29","TramadolHub",0,3,"","","tramadolhub-05292018","",0,[16,17,21],"","",""],["2018-05-29","XLPharmacy",0,3,"","","xlpharmacy-05292018","",0,[16,17,21],"","",""],["2018-05-23","IDT Australia Ltd.",0,3,"","Dr. Graeme R. Kaufman","idt-australia-ltd-547605-05232018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, IDT Australia Ltd. at 45 Wadhurst Drive, Boronia, from December 4 to 8, 2017. This warning letter summarizes significant deviations from current good manufacturing practice",0,[0,5,6,7,14,18],"3000219354","",""],["2018-05-23","Westcoast Radiology, Ltd",2,2,"","Kim Ridley","westcoast-radiology-ltd-554972-05232018","On September 18, 2017, a representative of the Food and Drug Administration (FDA) inspected your facility. This inspection revealed a serious problem involving the conduct of mammography at your facility. Under the Mammography Quality Standards Act of 1992 (MQ",0,[],"1000525950","",""],["2018-05-21","Oeyama-Moto-Medical Group Foundation, LLC",0,3,"","Benedict S. Liao, M.D.","oeyama-moto-medical-group-foundation-llc-552421-05212018","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at Oeyama-Moto Medical Group Foundation, Inc., West Covina, California, from August 7 to August 11, 2017. Mr. Johann M.",0,[],"3011596842","",""],["2018-05-18","Front Range Kratom",0,3,"","Gregory Todd Schulte","front-range-kratom-552391-05182018","This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.frontrangekratom.com in April 2018 and has determined that you take orders there for various kratom products, including but not limited to,",0,[16,17,19,21],"3014323888","",""],["2018-05-18","Jalco Cosmetics Pty Ltd.",0,3,"","Mr. Ian Martin","jalco-cosmetics-pty-ltd-546939-05182018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Jalco Cosmetics Pty. Ltd. at 45 King Rd, Hornsby, New South Wales, from December 11 to 13, 2017. This warning letter summarizes significant violations of current good manuf",0,[4,6,7,13,14,18],"3003906415","",""],["2018-05-18","Kolmar Korea Co. Ltd.",0,3,"","Mr. Dong-Hwan Yoon","kolmar-korea-co-ltd-542511-05182018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Kolmar Korea Co. Ltd., at 245 Sandan-gil, Jeonui-Myeon, Sejong-si, from September 25 to 28, 2017. This warning letter summarizes significant violations of current good manu",0,[7,14,15,18],"3004033751","",""],["2018-05-18","Kratom Spot",0,3,"","","kratom-spot-552370-05182018","",0,[16,17,19,21],"3014263307","",""],["2018-05-18","Revibe, Inc.",0,3,"","Augustine Hanger","revibe-inc-553137-05182018","",0,[16,17,19,21],"3014262613","",""],["2018-05-16","Europharma Concepts Limited",0,3,"","Mr. Michael Gilmore","europharma-concepts-limited-544738-05162018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Europharma Concepts Limited at Kilbeggan Road, Clara Tullamore, County Offaly, from October 31 to November 3, 2017. This warning letter summarizes significant violations of",0,[4,7,9,13,14,18],"3011798296","",""],["2018-05-14","Jilin Shulan Synthetic Pharmaceutical Co. Ltd.",0,3,"","Mr. Daqian Li","jilin-shulan-synthetic-pharmaceutical-co-ltd-546328-05142018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Jilin Shulan Synthetic Pharmaceutical Co., Ltd., at No. 2066 People\u2019s Main Road, Shulan City, Jilin Province, from November 7 to 10, 2017. This warning letter summarizes si",0,[0,5,6,7,14,15,18],"3003091092","",""],["2018-05-09","Nox Bellcow Cosmetics Co. Ltd.",0,3,"","Mr. Shi Da Lin","nox-bellcow-cosmetics-co-ltd-541734-05092018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Nox Bellcow Cosmetics Co., Ltd. at No. 50 Dognfu North Road, Nautou Town, Zhongshan City, Guangdong Province, from September 18 to 22, 2017. This warning letter summarizes",0,[0,3,6,7,13,14,15,18],"3006213806","",""],["2018-05-09","Reine Lifescience",0,3,"","Mr. Amish Shah","reine-lifescience-548293-05092018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Reine Lifescience, at Plot No. 5901, B H Sajjan India Limited, GIDC Industrial Estate, Ankleshwar, Gujurat, from October 30 to November 3, 2017. This warning letter summari",0,[0,3,5,18],"3011543431","",""],["2018-04-26","Option Care, Inc.",0,0,"","John C. Rademacher","option-care-inc-454500-04262018","The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our warning letter [Ref: 2015-DAL-WL-29] issued on August 27, 2015, following our inspection of your facility, Option Care, Inc. (formerly",0,[],"3011074473","",""],["2018-04-24","Goran Pharma Pvt Ltd",0,3,"","","goran-pharma-pvt-ltd-545331-04242018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Goran Pharma Private Limited at GDIC-I, Bhavnagar Road, Sihor, Gujarat, from November 13 to 15, 2017. This warning letter summarizes significant violations of current good",0,[2,13,14,18],"3009336980","",""],["2018-04-19","Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd.",0,3,"","","lijiang-yinghua-biochemical-and-pharmaceutical-co-ltd-544126-04192018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. at Nankou Industrial Park, Lijiang, Yunnan, from October 16 to 20, 2017. This warning letter summarizes significant",0,[0,6,7,14,18],"3005742706","",""],["2018-04-18","Degasa S.A. De C.V.",0,3,"","","degasa-sa-de-cv-542521-04182018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Degasa S.A. De C.V. at Calle 13 Este No. 580, Civac, Juitepec, Morelos, from September 4 to 8, 2017. This warning letter summarizes significant violations of current good m",0,[2,14,17,18,21],"3004555163","",""],["2018-04-09","McCallum Manufacturing Ltd",0,3,"","","mccallum-manufacturing-ltd-542286-04092018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, McCallum Manufacturing Ltd., at 6A-D, Redbrook Business Park, Withorpe Road, Barnsley, South Yorkshire, from July 24 to 26, 2017. This warning letter summarizes significant",0,[4,10,13,14,15,18],"3004464535","",""],["2018-04-06","Luen Wah (HK) Medicine Ltd",0,3,"","","luen-wah-hk-medicine-ltd-542595-04062018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Luen Wah (HK) Medicine Ltd. at 12 Ka Yip Street, Paramount Building 406, 412 Room, Chai Wan, Hong Kong Island, from September 25 to 28, 2017. This warning letter summarizes",0,[4,6,13,15,18],"3004962092","",""],["2018-04-05","Ming Fai Industrial -Shenzhen Co LTD",0,0,"","Mr. Chi Fai Ching","ming-fai-industrial-shenzhen-co-ltd-540570-04052018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Ming Fai Industrial, Shenzhen Co., Ltd. at Bainikeng, Pinhu Longgang, Shenzhen, Guangdong Province, from August 7 to 11, 2017. This warning letter summarizes significant vi",0,[4,6,9,14,15,18],"3003340745","",""],["2018-04-05","RadLogics, Inc.",2,3,"","","radlogics-inc-515599-04052018","The United States Food and Drug Administration (FDA) has learned that your firm, RADLogics, Inc. (\u201cRADLogics\u201d), is marketing AphaPoint Imaging Software (\u201cAlphaPoint\u201d), a radiological image analysis software application, in the United States without marketing c",0,[17,18,20],"3012236091","",""],["2018-03-29","Hanbul Cosmetics Co., Ltd",0,3,"","","hanbul-cosmetics-co-ltd-546445-03292018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, It\u2019S Hanbul Co., Ltd.; dba Hanbul Cosmetics Co., Ltd., 62, Daeseong-ro 547 Beon-gil, Samseong-myeon, Eumseong-gun, Chungcheongbuk-do, from November 27 to December 1, 2017.",0,[6,9,15,18],"3006755618","",""],["2018-03-23","Namsa",2,3,"","Jack M. Risdahl, D.V.M., Ph.D.","namsa-544884-03232018","This Warning Letter is to inform you of objectionable conditions observed during the Food and Drug Administration (FDA) inspection conducted at North American Science Associates (NAMSA), Inc. from November 1, 2017, to November 17, 2017, by an investigator from",0,[9,20],"3010138955","",""],["2018-03-15","Keshava Organics Pvt. Ltd.",0,3,"","Mr. Dinkar K. Raut","keshava-organics-pvt-ltd-540146-03152018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Keshava Organics Pvt. Ltd. at T-97 & 100, MIDC-Tarapur, Dist. Thane, Maharashtra, from May 25 to 31, 2017. This warning letter summarizes significant deviations of current",0,[7,14,18],"3003677831","",""],["2018-03-09","Fujifilm",2,3,"","Takaaki Ueda","fujifilm-546987-03092018","The United States Food and Drug Administration (FDA) is issuing this Warning Letter to inform you of Fujifilm Medical System U.S.A., Inc.\u2019s failure to comply with requirements under section 522 of the Federal Food, Drug and Cosmetic Act (the Act) (21 U.S.C. \u00a7",0,[17],"3001722928","",""],["2018-03-09","Labocont Industrial SRL",0,3,"","Mr. Leodoro A. Contreras","labocont-industrial-srl-537663-03092018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Labocont Industrial SRL at Entrada Zona Franca, La Caleta Autopista Las Am\u00e9ricas, Km 19 Santo Domingo, from June 5 to 9, 2017. This warning letter summarizes significant vi",0,[3,14,18],"3010166941","",""],["2018-03-09","Malladi Drugs & Pharmaceuticals Ltd.",0,3,"","V.N. Gopalkrishnan","malladi-drugs-pharmaceuticals-ltd-541915-03092018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Malladi Drugs & Pharmaceuticals Limited, Unit 1, at 67 SIPCOT Industrial Complex, Ranipet, Vellore District, Tamil Nadu, from September 4 to 8, 2017. This warning letter su",0,[4,6,7,9,14,18],"3005115135","",""],["2018-03-09","Olympus Medical Systems Corporation",2,3,"","Nacho Abia","olympus-medical-systems-corporation-546986-03092018","The United States Food and Drug Administration (FDA) is issuing this Warning Letter to inform you of Olympus Corporation of the Americas\u2019s failure to comply with requirements under section 522 of the Federal Food, Drug and Cosmetic Act (the Act) (21 U.S.C. \u00a7 3",0,[17],"3002807795","",""],["2018-03-05","Quali Controle & Qual-Controle-C.E.Bac",0,3,"","Mr. Emmanuel Souhaut","quali-controle-qual-controle-cebac-542283-03052018","The U.S. Food and Drug Administration (FDA) inspected your drug contract testing laboratory, Quali-Controle & Quali-Controle C.E.BAC, at 29 Rue Paul Vaillant-Couturier, Meru, from September 14 to 15, 2017. This warning letter summarizes significant violations",0,[7,14,18],"3002807958","",""],["2018-02-23","Nan San (HK) Pharmaceutical Factory Ltd.",0,3,"","Ms. Cheuk Yin Cheung","nan-san-hk-pharmaceutical-factory-ltd-542072-02232018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Nan San (HK) Pharmaceutical Factory Limited at Hoi Bun Industrial Building, 6 Wing Yip Street, Unit C1, 10/F, Kwun Tong Kowloon, Hong Kong, from September 25 to 29, 2017. T",0,[4,6,17,18,21],"3003723042","",""],["2018-02-23","Zhejiang Ludao Technology Co., Ltd.",0,3,"","Mr. Wang Xiaobing","zhejiang-ludao-technology-co-ltd-541460-02232018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Zhejiang Ludao Technology Co., Ltd., No. 5 Industry Road, Hairun Street, Sanmen County, Taizhou, from August 14 to 18, 2017. This warning letter summarizes significant viol",0,[0,6,13,14,18],"3006460758","",""],["2018-02-20","Dexcowin Co. Ltd.",2,3,"","Raymond Ryu","dexcowin-co-ltd-545388-02202018","During an inspection of your firm located in Seoul, Republic of Korea,on August 28, 2017, through August 31, 2017, an investigatorfrom the United States Food and Drug Administration (FDA) determined that your firm manufactures portable dental diagnostic X-ray",0,[4,9,11,12,13,17,18],"3007065358","",""],["2018-02-20","Neo Vision Co Ltd",2,3,"","Kyung-Hwa Kim","neo-vision-co-ltd-506797-02202018","The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our letter (CMS# 506797) dated September 14, 2016. Based on our evaluation, it appears that you have addressed the violations contained in the letter.",0,[],"3009674807","",""],["2018-02-16","Alchymars ICM SM Private Limited",0,3,"","Mr. T.G. Velumani","alchymars-icm-sm-private-limited-542879-02162018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Alchymars ICM SM Private Limited at A-14 & 20 Complex, Alathur, Tamil Nadu, from September 11 to 15, 2017. This warning letter summarizes significant deviations from curren",0,[0,7,10,14,18],"3005216842","",""],["2018-02-14","Nowcos Co., Ltd",0,3,"","Mr. Hyang Seon Ro","nowcos-co-ltd-541054-02142018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Nowcos Co., Ltd. at 37 Ayamok-gil, Sojeong-myeon, Sejong-Si, from July 31 to August 4, 2017. This warning letter summarizes significant violations of current good manufactu",0,[3,4,6,18],"3009968674","",""],["2018-02-12","Casmara Cosmetics, S.A.",0,3,"","Mr. Jose Sequi Gonzalez","casmara-cosmetics-sa-538047-02122018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Casmara Cosmetics, S. A., at Calle Ciudad de Lira, No. 29 y 31, Paterna (Valencia), from May 29 to 31, 2017. This warning letter summarizes significant violations of curren",0,[4,6,7,13,15,18],"3004619185","",""],["2018-02-07","Shanghai Weierya Daily Chemicals Factory",0,3,"","Mr. Zhifang Ma","shanghai-weierya-daily-chemicals-factory-536348-02072018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Shanghai Weierya Daily Chemicals Factory at No. 1072 Dongsheng Road, Shanghai, from April 10 to 14, 2017. This warning letter summarizes significant violations of current g",0,[13,14,15,18],"3010166363","",""],["2018-02-02","Cosmecca Korea Co., Ltd.",0,3,"","Mr. Im-Rae Cho","cosmecca-korea-co-ltd-543188-02022018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Cosmecca Korea Co., Ltd. at 17-12 Daegeum-ro 196 beon-gil, Daeso-myeon, Eumseong-gun, Chungcheongbuk-do, from September 18 to 22, 2017. This warning letter summarizes signi",0,[0,6,7,14,15,18],"3010165567","",""],["2018-01-26","Celltrion Inc.",0,3,"","Mr. Woo Sung Kee","celltrion-inc-534262-01262018","",0,[1,2,6,7,8,15,18],"3005241015","",""],["2018-01-25","Polaroisin International Co., Ltd.",0,3,"","Mr. Li Chung Lung","polaroisin-international-co-ltd-541792-01252018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Polaroisin International Co., Ltd. at Xinzhuang District, NO 173, 10F, Siyuan Road, New Taipei City, from September 11 to 15, 2017. This warning letter summarizes significa",0,[4,6,13,18,21],"3008004582","",""],["2018-01-18","Daito Kasei Kogyo Co Ltd",0,3,"","Mr. Kazumasa Koyama","daito-kasei-kogyo-co-ltd-539236-01182018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Daito Kasei Kogyo Co., LTD., at 441 Kadani, Bizen, Okayama, from July 18 to 21, 2017. This warning letter summarizes significant deviations from current good manufacturing",0,[0,14,18],"1000223178","",""],["2018-01-11","Guna Inc.",0,3,"","Mr. Alessandro Pizzoccaro","guna-inc-542995-01112018","This is to advise you that the U.S. Food and Drug Administration (FDA) and the U.S. Federal Trade Commission (FTC) reviewed your website at https://gunainc.com/, from which you take orders for your GUNA-ADDICT 1 product. FDA has determined that your GUNA-ADDIC",0,[16,17,18,19,21],"3007894121","",""],["2018-01-11","King Bio Inc.",0,3,"","Dr. Frank J. King, Jr.","king-bio-inc-542987-01112018","This is to advise you that the U.S. Food and Drug Administration (FDA) and the U.S. Federal Trade Commission (FTC) reviewed your website at www.drkings.com, from which you take orders for your AddictaPlex product. We also reviewed your social media website at",0,[16,17,18,19,21],"1053442","",""],["2018-01-11","Wong Lap Kwong Medicine Company Limited",0,3,"","Ms. Amy Wing Mui Wong","wong-lap-kwong-medicine-company-limited-542586-01112018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Wong Lap Kwong Medicine Company Limited at Flat B, 4/F, Wah Lung Industrial Building, 49-53 Wang Lung Street, Tseun Wan, New Territories from September 18 to 22, 2017. This",0,[4,7,10,13,14,15,18],"3003338476","",""],["2018-01-09","Hunan Norchem Pharmaceutical Co. Ltd.",0,3,"","Mr. Xirong Liu","hunan-norchem-pharmaceutical-co-ltd-538815-01092018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Hunan Norchem Pharmaceutical Co. Ltd. at No. 20 Mengjiangnv Avenue, Economic Development Zone, Jinshi, Hunan, from July 24 to 28, 2017. This warning letter summarizes signi",0,[0,14,15,18],"3010784755","",""],["2018-01-01","Yicheng Chemical Corp.",0,3,"","Ms. Yan Chen","yicheng-chemical-corp-539843-01012018","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Yicheng Chemical Corporation at Fuchen Garden, Suite 1-402, Xinbei District, Changzhou, Jiangsu, from July 17 to 21, 2017. This warning letter summarizes significant deviat",0,[3,14,15,18],"3004102971","",""],["2017-12-28","Investra-24hs",0,3,"","","investra-24hs-543610-12282017","",0,[16,17,21],"3014126314","",""],["2017-12-21","Imprimis Pharmaceuticals",0,3,"","Mark Baum","imprimis-pharmaceuticals-540678-12212017","This is to advise your firm that the U.S. Food and Drug Administration (FDA) has reviewed promotional materials disseminated by your firm, including the website at www.imprimisrx.com 1 where you take orders for the following compounded drug products: \u2022 \u201cDrople",0,[17,19,21],"","",""],["2017-12-20","Schrofner Cosmetics Gmbh",0,3,"","Mr. Stefan Schrofner","schrofner-cosmetics-gmbh-538117-12202017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Schrofner Cosmetics GmbH, at Robiningstrabe 26a, Salzburg, from July 17\u201319, 2017. This warning letter summarizes significant violations of current good manufacturing practi",0,[3,4,7,13,14,15,18],"3010632712","",""],["2017-12-19","Delta Laboratories Pty Ltd",0,3,"","Mr. Gary Leach","delta-laboratories-pty-ltd-537641-12192017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Delta Laboratories Pty. Ltd. at 8 Warringah CL, Somersby, from March 27\u201331, 2017. This warning letter summarizes significant violations of current good manufacturing practi",0,[4,6,7,14,18],"3004085558","",""],["2017-12-18","Deserving Health International Corp",0,3,"","Mr. Bernard Armani","deserving-health-international-corp-539295-12182017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Deserving Health International Corp. at 13160 Vanier Place, Unit 110, Richmond, British Columbia, from July 10 to 14, 2017. This warning letter summarizes significant viola",0,[1,2,3,6,14,15,18],"3012271380","",""],["2017-12-18","Wuhan Chinese Moxibustion Technology Dev. Co., Ltd.",0,3,"","Mr. Jinlong Fu","wuhan-chinese-moxibustion-technology-dev-co-ltd-537648-12182017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Wuhan Chinese Moxibustion Technology Dev. Co., Ltd., at Wuhan Pharmaceutical Industry Park, East Lake High-Tech Development District, Miaoshan, Wuhan, Hubei, from May 22 to",0,[3,4,14,15,17,18],"3004859058","",""],["2017-12-17","Fresenius Kabi Oncology Limited (Baddi)",0,0,"","Mats Henriksson","fresenius-kabi-oncology-limited-baddi-526863-12172017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Fresenius Kabi Oncology Limited Baddi at Kishanpura Village, Baddi, Gurumajra, Himachal Pradesh, India, from April 6 to 14, 2017. This warning letter summarizes significant",0,[1,2,7,8,18],"3006210232","",""],["2017-12-17","Prosana Distribuciones SA de CV",0,0,"","Mr. Fernando Vidal Millan","prosana-distribuciones-sa-de-cv-527967-12172017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Prosana Distribuciones S.A. de C.V. at Oriente 225 97-1 Agricola Oriental, Iztacalco, Mexico City, from March 6\u20139, 2017. This warning letter summarizes significant violatio",0,[0,4,6,13,14,15,16,17,18],"3011473501","",""],["2017-12-13","Amaros Co., Ltd",0,3,"","Mrs. Sun A. Kim","amaros-co-ltd-533321-12132017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Amaros Co., Ltd. at Jungwon-gu, 560 Dunchon-daero, Seongnam-si, from May 8\u201312, 2017. This warning letter summarizes significant violations of current good manufacturing pra",0,[13,14,18],"3010518986","",""],["2017-12-13","AN Co. Ltd.",0,3,"","Park Soung Lul","co-ltd-538516-12132017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, AN Co. Ltd at 1452-248 Yeongdong Hwanggan-ro Hwanggan-myeon, Yeongdong-gun Chungcheongbuk-do, from May 29\u201330, 2017. This warning letter summarizes significant violations of",0,[4,6,7,14,18],"3003092574","",""],["2017-12-11","Arco Globus Trading LLC",0,3,"","Abe Citron","arco-globus-trading-llc-538080-12112017","",0,[16,17,21],"3013634251","",""],["2017-12-05","Aphena Pharma Solutions-Tennessee, LLC",0,3,"","David Loy","aphena-pharma-solutions-tennessee-llc-542310-12052017","",0,[17],"3003849479","",""],["2017-12-05","Seindni Co., Ltd.",0,0,"","Mr. Il Chong Chung","seindni-co-ltd-533363-12052017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Seindni Co., Ltd. at 610-304, 16, Gireum-ro, Seongbuk-gu, Seoul from May 25\u201326, 2017. This warning letter summarizes significant violations of current good manufacturing pr",0,[13,14,18],"3011476755","",""],["2017-12-04","Fresenius Kabi Oncology Ltd",0,3,"","Mr. Mats Henrikkson","fresenius-kabi-oncology-ltd-538641-12042017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Fresenius Kabi Oncology Ltd at D-35, Industrial Area, Kalyani, Nadia, West Bengal, from May 15 to May 24, 2017. This warning letter summarizes significant deviations from c",0,[5,7,18],"3003519498","",""],["2017-12-04","Shanwei Honghui Daily Appliance Co., Ltd.",0,0,"","Mr. Weishan Song","shanwei-honghui-daily-appliance-co-ltd-539705-12042017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Shanwei Honghui Daily Appliance Co., Ltd., at Chunzai Garden Wuya Hong Cao Town, Shanwei, Guangdong Province, from July 31 to August 3, 2017. This warning letter summarizes",0,[15,18],"3011155936","",""],["2017-11-29","BBCOS srl",0,3,"","Mr. Raffaele Bertola","bbcos-srl-541045-11292017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, BBCOS srl at Via del Lavoro, 37 Loc. Cappellazzo, 12062 Cherasco from June 19\u201323, 2017. This warning letter summarizes significant violations of current good manufacturing",0,[6,18],"3006447041","",""],["2017-11-20","Dae Young Foods Co., Ltd.",0,3,"","Mr. JongWoo Kim","dae-young-foods-co-ltd-527505-11202017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Dae Young Foods at 32 Gumgul-4-gil Boeun-eup, Boeun-gun, Chungchongbuk-do, from March 13 to 17, 2017. This warning letter summarizes significant violations of current good",0,[13,14,15,17,18,21],"3009719616","",""],["2017-11-17","Hangzhou Facecare Cosmetics Co., Ltd.",0,3,"","Mr. Zhigang Wu","hangzhou-facecare-cosmetics-co-ltd-537146-11172017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Hangzhou Facecare Cosmetics Co., Ltd. at 755 Yinhai Road, HEDA, Hangzhou, from June 19 to 22, 2017. This warning letter summarizes significant violations of current good ma",0,[6,13,18],"3008655176","",""],["2017-11-14","Bayer Pharma AG",0,3,"","Werner Baumann","bayer-pharma-ag-526288-11142017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Bayer Pharma AG at Kaiser-Willhelm-Allee, Building W11, Leverkusen, from January 12\u201320, 2017. This warning letter summarizes significant violations of current good manufact",0,[0,3,4,14,18],"3002806462","",""],["2017-11-14","TELEMED",2,3,"","Dmitry Novikov","telemed-540646-11142017","During an inspection of your firm located in Vilnius, Lithuaniaon July 31 to August 3, 2017, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures diagnostic ultrasound systems. Under section 201(h) of",0,[4,9,10,11,12,13,18,20],"3007994837","",""],["2017-11-06","Hubei Danao Pharmaceutical Co., Ltd.",0,3,"","Mr. Cui Lixin","hubei-danao-pharmaceutical-co-ltd-539667-11062017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Hubei Danjiangkou Danao Pharmaceutical Co., Ltd. at Fandan Road, Danjiangkou, Hubei Province, from July 31 to August 4, 2017. This warning letter summarizes significant dev",0,[4,14,15,18],"3004881534","",""],["2017-11-06","Lupin Limited",0,3,"","Mr. Nilesh Gupta","lupin-limited-535014-11062017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facilities: Lupin Limited at 15-B, Phase 1A, Verna Industrial Area, Verna, Salcette, Goa from March 27 to April 7, 2017 (\u201cLupin Goa\u201d) and Lupin Limited at Unit 2\u2013Plot No. 2, SEZ Phas",0,[6,7,18],"3007549629","",""],["2017-11-01","Guangzhou Baiyunshan Pharmaceutical Co., Ltd.",0,3,"","Mr. Yanzhong Yang","guangzhou-baiyunshan-pharmaceutical-co-ltd-534559-11012017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Baiyunshan Hejigong Pharmaceutical Factory at No. 52 Xiao Gang Dama Road, XinShi Street, Guangzhou, Guangdong from May 22\u201325, 2017. This warning letter summarizes significa",0,[3,15,17,18,21],"3004506176","",""],["2017-10-30","Guangdong Zhanjiang Jimin Pharmaceutical Co., Ltd.",0,3,"","Mr.Guangjian Feng","guangdong-zhanjiang-jimin-pharmaceutical-co-ltd-534215-10302017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Guangdong Zhanjiang Jimin Pharmaceutical Co., Ltd., at No. 59 South Renming Road, Zhangjiang City, Guangdong, from May 15\u201319, 2017. This warning letter summarizes significa",0,[4,14,15,16,17,18],"3004060039","",""],["2017-10-30","Opternative Inc",2,3,"","Aaron Dallek","opternative-inc-532477-10302017","The United States Food and Drug Administration (FDA) has learned that your firm is marketing the On-Line Opternative Eye Examination Mobile Medical App device in the United States without marketing clearance or approval, in violation of the Federal Food, Drug,",0,[17,18,20],"","",""],["2017-10-22","Ironmag Labs",0,0,"","Robert and Gena Dimaggio","ironmag-labs-494623-10222017","This is to advise you that your firm\u2019s distribution of the product \u201cSuper DMZ 4.0\u201d violates the Federal Food, Drug, and Cosmetic Act (FD&C Act), as described below. The Food and Drug Administration has significant safety concerns about your product(s) marketed",0,[16,17,21],"3011020174","",""],["2017-10-20","Aztex Enterprises Ltd.",0,3,"","Mr. Grant Gillard","aztex-enterprises-ltd-538947-10202017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Aztex Enterprises Ltd. at 5155 Fairview Street, Burlington, Ontario, Canada, from June 12 to June 13, 2017. This warning letter summarizes significant violations of current",0,[10,14,18],"3003516782","",""],["2017-10-20","GPC Medical Ltd.",2,3,"","Mr. Vikas Narang","gpc-medical-ltd-536145-10202017","",0,[4,18,20],"3006513362","",""],["2017-10-16","Kim Chemicals Private Ltd.",0,3,"","Mr. Bhagwan Chandanai","kim-chemicals-private-ltd-535531-10162017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Kim Chemicals Private Ltd., at Plot No. G-13/16 MIDC, Taloja, Raigad, Maharashtra, from June 5 to 9, 2017. This warning letter summarizes significant violations of current",0,[0,6,7,10,14,16,17,18],"3006370331","",""],["2017-10-10","Sohail M. Khan, M.D.",0,3,"","Sohail M. Khan, M.D.","sohail-m-khan-md-539274-10102017","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site on July 14, 2017. Ms. Cynthia Rakestraw, representing FDA, reviewed your conduct of the following",0,[],"3012366186","",""],["2017-10-10","Vital Laboratories Pvt Ltd Plant II",0,3,"","Mr. Rajiv Bajaj","vital-laboratories-pvt-ltd-plant-ii-527253-10102017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Vital Laboratories Private Limited Plant-II, at Plot No.1710 & A1-2208, Phase III GIDC Estate, Vapi, Gujarat, from April 3\u20136, 2017. This warning letter summarizes significa",0,[6,7,14,15,18],"3007474872","",""],["2017-09-25","UVLRX Therapeutics Inc",2,3,"","Victor Scheeren","uvlrx-therapeutics-inc-533314-09252017","This Warning Letter is to inform you of objectionable conditions observed during the Food and Drug Administration (FDA) inspection conducted at UVLrx Therapeutics, Inc. from March 27, 2017, to April 4, 2017, by an investigator from the FDA BIMO EAST Division.",0,[0,20],"3011422619","",""],["2017-09-22","Dasan E&T Co., Ltd.",0,3,"","Ms. Jeong Soo Ahn","dasan-et-co-ltd-525897-09222017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Dasan E&T Co., Ltd., Inc. at 98, Samdo-Ro, Yangchon-Eup, Gimpo-Si, Gyeonggi-Do Gimpo, Kyonggi-do, from January 23\u201326, 2017. This warning letter summarizes significant viola",0,[4,6,14,18],"3010829786","",""],["2017-09-20","ELITech Group B.V.",2,3,"","Christoph Gauer","elitech-group-bv-534429-09202017","During an inspection of your firm located in Spankeren, The Netherlands on March 27, 2017, through March 30, 2017, an investigatorfrom the United States Food and Drug Administration (FDA) determined that your firm manufactures the Selectra Pro S, Selectra Pro",0,[3,9,10,11,13,17,18],"3001576181","",""],["2017-09-20","Euro Diagnostica AB",2,3,"","Ms. Else Beth Trautner","euro-diagnostica-ab-524316-09202017","During an inspection of your firm located in Malmo, Skane, Sweden on 01/16/2017 through 01/19/2017 an investigatorfrom the United States Food and Drug Administration (FDA) determined that your firm manufactures multiple class II in vitro diagnostic (IVD) devic",0,[9,10,11,12,17,18],"3007610287","",""],["2017-09-19","247Med",0,3,"","","247med-09192017","",0,[16,17,21],"","",""],["2017-09-19","American Pharmacy Group",0,3,"","","american-pharmacy-group-09192017","",0,[16,17,21],"","",""],["2017-09-19","Bulk2USA",0,3,"","","bulk2usa-09192017","",0,[16,17,21],"","",""],["2017-09-19","CanAmerica Global",0,3,"","","canamerica-global-09192017","",0,[16,17,21],"","",""],["2017-09-19","DRG Instruments GmbH",2,3,"","Wilhelm S\u00e4nger","drg-instruments-gmbh-522669-09192017","During an inspection of your firm located in Marburg, Germany on October 24, 2016, through October 28, 2016, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures 17-alpha-OH Progesterone ELISA, Saliva",0,[9,17,18,20],"3002800697","",""],["2017-09-19","GlavMed",0,3,"","","glavmed-09192017","",0,[16,17,21],"","",""],["2017-09-19","HA Stores, Ltd",0,3,"","","ha-stores-ltd-09192017","",0,[16,17,21],"","",""],["2017-09-19","Medicina Mexico",0,3,"","","medicina-mexico-09192017","",0,[16,17,21],"","",""],["2017-09-19","MediPK",0,3,"","","medipk-09192017","",0,[16,17,21],"","",""],["2017-09-19","MyRXCash",0,3,"","","myrxcash-09192017","",0,[16,17,21],"","",""],["2017-09-19","PharmCash",0,3,"","","pharmcash-09192017","",0,[16,17,21],"","",""],["2017-09-19","Pharmempire",0,3,"","","pharmempire-09192017","",0,[16,17,21],"","",""],["2017-09-19","Rx-Partners",0,3,"","","rx-partners-09192017","",0,[16,17,21],"","",""],["2017-09-19","Worldwide Drug Store",0,3,"","","worldwide-drug-store-09192017","",0,[16,17,21],"","",""],["2017-09-15","Alber GmbH",2,3,"","Mr. Hansjorg Reiner","alber-gmbh-532755-09152017","During an inspection of your firm located in Albstadt Beden-Wurttemberg, Germany on May 8, 2017 through May 11, 2017, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures wheelchair power drive add-on",0,[9,10,12,18,20],"3004730072","",""],["2017-09-12","Jiangmen Nowadays Daily Goods Co., Ltd.",0,3,"","Mr. Li Jin Zhao","jiangmen-nowadays-daily-goods-co-ltd-526243-09122017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Jiangmen Nowadays Daily Goods Co., Ltd., at Boyukou Liangde Chong Industrial Zone, Sanjiang Town, Xinhui District, Jiangmen, Guangdong, from March 6 to 9, 2017. This warnin",0,[4,13,18],"3009490758","",""],["2017-09-12","Shandong Vianor Biotech Co., Ltd.",0,3,"","Ms. Cui Shanshan","shandong-vianor-biotech-co-ltd-534541-09122017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Shandong Vianor Biotech Company at Science Park, West End Naning Road, Nanfang, Lanshan District, Linyi Shandong, from May 8 to 10, 2017. This warning letter summarizes sig",0,[14,18],"3011717652","",""],["2017-09-07","Wuxi Medical lnstrument Factory",0,3,"","Mr. Chongjiu Li","wuxi-medical-lnstrument-factory-525538-09072017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Wuxi Medical Instrument Factory at No. 43 Xixin Road, Zhangjing, Xibei Town, Wuxi City Jiangsu, from March 6 to 10, 2017. This warning letter summarizes significant violati",0,[0,2,4,15,18],"3006851654","",""],["2017-08-31","Firson Co., Ltd.",0,3,"","Mr. Kim Dong-Jin","firson-co-ltd-523784-08312017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Firson Co. Ltd. at 47 Handeul 1-ro, Seobuk-gu, Cheonan-si, Chungcheongnam-do, from November 3 to 11, 2016. This warning letter summarizes significant violations of current",0,[1,2,9,10,14,15,18],"3010219111","",""],["2017-08-23","Curasan AG, Frankfurt Facility",2,3,"","Mr. Michael Schlenk","curasan-ag-frankfurt-facility-534581-08232017","During an inspection of your firm located in Frankfurt, Germany on May 8, 2017 through May 11, 2017 an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Cerasorb Dental, Cerasorb M Dental, Cerasorb Pe",0,[10,11,12,17,18,20],"3004847139","",""],["2017-08-15","Hetero Labs Limited Unit V",0,3,"","Dr. Bandi Parthasarathy Reddy","hetero-labs-limited-unit-v-520359-08152017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Hetero Labs Limited, Unit V at Polepally Village, Jadcherla Mandal, Mahaboob Nag, Telangana, from December 7\u201316, 2016. This warning letter summarizes significant violations",0,[3,4,6,7,10,14,18],"3008307735","",""],["2017-08-11","Bicooya Cosmetics Limited",0,3,"","Mr. Tao Yang","bicooya-cosmetics-limited-533477-08112017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Bicooya Cosmetics Limited at No. 17, Yan Hu Road, Shangxi Town, Zhejiang, from May 22\u201325, 2017. This warning letter summarizes significant violations of current good manufa",0,[0,3,6,15,18],"3010671652","",""],["2017-08-04","Laveeza (nmi) Bhatti, M.D.",0,3,"","Laveeza (nmi) Bhatti, M.D.","laveeza-nmi-bhatti-md-538090-08042017","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between October 27 and December 16, 2016. Ms. Yvonne T. LaCour, representing FDA, reviewed your c",0,[],"3012690073","",""],["2017-08-04","MB Industria Cirurgica Ltda",2,3,"","","mb-industria-cirurgica-ltda-532799-08042017","",0,[2,9,10,11,17,18,20],"3008392077","",""],["2017-08-02","Cellex-C International Inc.",0,3,"","","cellex-c-international-inc-521113-08022017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Cellex-C International Inc. at 9 New Street, Toronto, from January 16 to 19, 2017. This warning letter summarizes significant violations of current good manufacturing pract",0,[13,14,15,18],"3003525539","",""],["2017-08-02","Homeolab USA Inc.",0,3,"","","homeolab-usa-inc-523072-08022017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Homeolab USA Inc. (part of the parent company, Homeocan Inc.) at 3025 De L\u2019Assomption Blvd., Montreal, Qu\u00e9bec, from January 9 to 13, 2017. This warning letter summarizes si",0,[4,13,14,18],"1000399435","",""],["2017-08-01","Foshan Flying Medical Products Co., Ltd.",0,3,"","","foshan-flying-medical-products-co-ltd-523699-08012017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Foshan Flying Medical Products Co., Ltd. at Zumiao 1st Road, Chancheng, Xiaofengtian Industrial District, Wuzhuang, Luocun Town, Foshan City, Guangdong Province from Februa",0,[2,4,14,15,18],"3009206013","",""],["2017-07-31","SyncThink, Inc.",2,3,"","","syncthink-inc-498523-07312017","The United States Food and Drug Administration (FDA) has learned that your firm is marketing the EYE-SYNC device in the United States, without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act). Under Section 20",0,[17,18,20],"3014133165","",""],["2017-07-28","Skin Sciences Laboratory, Inc.",0,3,"","","skin-sciences-laboratory-inc-524185-07282017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Skin Sciences Laboratory Inc. at Unit 101 Central Business Park, Amang Rodriguez Avenue, Manggahan Pasig City, from January 30 to February 1, 2017. This warning letter summ",0,[14,16,17,18,21],"3006375239","",""],["2017-07-20","HOSPIMED",2,3,"","","hospimed-510526-07202017","",0,[17,18,20],"3006948745","",""],["2017-07-06","Tubilux Pharma Spa",0,3,"","","tubilux-pharma-spa-523119-07062017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Tubilux Pharma S.p.A. at Via Costarica 20/22, 00071 Pomezia, Rome, from December 1 to 9, 2016. This warning letter summarizes significant violations of current good manufac",0,[1,2,18],"3003854110","",""],["2017-07-05","Vista Pharmaceuticals Limited",0,3,"","","vista-pharmaceuticals-limited-515652-07052017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Vista Pharmaceuticals Limited at APIIC Industrial Estate, Gopalapalli, Narketpalli, Nalgonda, Telangana, from September 19 to 23, 2016. This warning letter summarizes signi",0,[4,17,18,21],"3003978209","",""],["2017-06-22","Shandong Analysis and Test Center",0,3,"","","shandong-analysis-and-test-center-524254-06222017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Shandong Analysis and Test Center at 19 Keyuan Road, Jinan, Shandong, from January 16\u201318, 2017. This warning letter summarizes significant deviations from current good manu",0,[5,14,18],"3011060456","",""],["2017-06-21","Steiner Laboratories",2,3,"","Gregory G. Steiner, DDS","steiner-laboratories-518625-06212017","This Warning Letter is to inform you of objectionable conditions observed during the Food and Drug Administration (FDA) inspection conducted at Steiner Biotechnology from December 12, 2016, to December 16, 2016, by an investigator from the FDA San Francisco Di",0,[20],"3005138409","",""],["2017-06-07","Olympus Corporation of the Americas",2,2,"","Akihiro Okubo","olympus-corporation-americas-470191-06072017","The Food and Drug Administration (FDA) has completed an evaluation of your firm\u2019s corrective actions in response to our Warning Letter dated August 12, 2015. Based on our evaluation, it appears that your firm has adequately addressed the violations contained i",0,[],"1000635022","",""],["2017-06-05","A-S Medication Solutions LLC.",0,3,"","Walter Hoff","s-medication-solutions-llc-522197-06052017","The United States Food and Drug Administration (FDA), has manually reviewed over (b)(4) of your firm\u2019s listing files between May 2016 and March 2017 and has identified many instances where the listing information failed to comply with the applicable requiremen",0,[17],"1450743","",""],["2017-06-01","Prestige Brands Holdings",0,3,"","","prestige-brands-holdings-524921-06012017","",0,[17],"3010282778","",""],["2017-05-26","Pacific Hospital Supply Co., Ltd.",2,3,"","Chin-Hui Liao","pacific-hospital-supply-co-ltd-522616-05262017","During an inspection of your firm located in Miaoli, Taiwan on February 20, 2017, through February 22, 2017,an investigatorfrom the United States Food and Drug Administration (FDA) determined that your firm manufactures disposable medical supplies including ca",0,[9,15,18,20],"3014615028","",""],["2017-05-11","Changzhou Jintan Qianyao Pharmaceutical Raw Materials",0,3,"","","changzhou-jintan-qianyao-pharmaceutical-raw-materials-521381-05112017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Changzhou Jintan Qianyao Pharmaceutical Raw Materials at No. 678 Zhuangcheng, Changzhou, Jintan, from February 13\u201317, 2017. This warning letter summarizes significant devia",0,[0,15,18],"3005587213","",""],["2017-05-08","Oculo-Plastik, Inc.",2,0,"","Jean-Francois Durette","oculo-plastik-inc-481113-05082017","The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter 481113, dated December 22, 2015. Based on our evaluation, it appears that you have addressed the violations contained in this",0,[],"3002513507","",""],["2017-04-28","Vikshara Trading & Investments Ltd.",0,3,"","","vikshara-trading-investments-ltd-516856-04282017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Vikshara Trading & Investments Ltd at Opp: Anup Engineering, Odhav Road, Ahmedabad, Gujarat, on October 18, 2016. Our investigator documented that your firm delayed and lim",0,[15,18],"3004982352","",""],["2017-04-24","Qinhuangdao Zizhu Pharmaceutical, Co.",0,3,"","","qinhuangdao-zizhu-pharmaceutical-co-517793-04242017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Qinhuangdao Zizhu Pharmaceutical Co., Ltd. at No. 10 Longhai Avenue, Economic Development Zone, Qinhuangdao, Hebei from November 28 to December 1, 2016. This warning letter",0,[0,6,14,15,18],"3009653722","",""],["2017-04-20","Adolfo Kaplan",0,3,"","","adolfo-kaplan-523832-04202017","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between November 7 and November 10, 2016. Mr. Travis M. Beard, representing FDA, reviewed your co",0,[],"3012716728","",""],["2017-04-20","Sal Pharma",0,3,"","","sal-pharma-516205-04202017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Sal Pharma, at 1-7-171/2 Bakaram, Hyderabad, Andhra Pradesh, from June 27 to July 1, 2016. This warning letter summarizes significant deviations from current good manufactu",0,[17,18],"3003916387","",""],["2017-04-19","Exact-Rx Inc",0,3,"","","exact-rx-inc-518302-04192017","The United States Food and Drug Administration (FDA), has reviewed your firm\u2019s listing information provided for Exact-Rx Sodium Sulfacetamide and Sulfer 10%/5% Cleanser, NDC 42808-112. Our review revealed that the listing for this product is inaccurate. Prompt",0,[17],"3004000544","",""],["2017-04-13","Divi's Laboratories Ltd. (Unit II)",0,3,"","Mr. Kiran Divi","divis-laboratories-ltd-unit-ii-518434-04132017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Divi\u2019s Laboratories Ltd. (Unit II) at Unit-2, Chippada Village, Visakhapatnam District, from November 29 to December 6, 2016. This warning letter summarizes significant dev",0,[0,6,7,14,18],"3004149463","",""],["2017-04-12","Abbott (St Jude Medical Inc.)",2,3,"","","abbott-st-jude-medical-inc-519686-04122017","During an inspection of your firm located in Sylmar, CA,on February 7 through February 17, 2017, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Fortify, Unify, Assura (including Quadra) implan",0,[9,12,18,20],"2017865","",""],["2017-04-06","Bebe Toys Manufactory Ltd.",2,3,"","Chan Ming Kei","bebe-toys-manufactory-ltd-512794-04062017","During an inspection of your firm located in Dongguan, China, on September 19, 2016, through September 22, 2016, an investigatorfrom the United States Food and Drug Administration (FDA) determined that your firm manufactures water filled teething devices . Und",0,[2,9,12,13,18,20],"","",""],["2017-04-06","Entellus Medical",2,3,"","","entellus-medical-511495-04062017","This Warning Letter is to inform you of objectionable conditions observed during the Food and Drug Administration (FDA) inspection conducted at Entellus Medical, Inc., from September 6, 2016, to September 27, 2016, by investigators from the FDA Minneapolis Dis",0,[20],"3015967359","",""],["2017-04-05","Teva Pharmaceutical and Chemical (Hangzhou) Co. Ltd.",0,3,"","","teva-pharmaceutical-and-chemical-hangzhou-co-ltd-516381-04052017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Teva Pharmaceutical and Chemical (Hangzhou) Co. Ltd., 1889 Jingliu Road, Xiaoshan, Hangzhou, Zhejiang, China from September 26 to 29, 2016. This warning letter summarizes s",0,[4,6,7,9,18],"3009271645","",""],["2017-04-03","Mylan Laboratories Limited, (Nashik FDF)",0,3,"","Mr. Rajiv Malik","mylan-laboratories-limited-nashik-fdf-517906-04032017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Mylan Laboratories Limited at F-4 & F-12, MIDC, Malegaon Taluka, Sinnar District, Nashik 422 113, Maharashtra, India, from September 5 to 14, 2016. This warning letter summ",0,[0,7,14,18],"3005587313","",""],["2017-03-29","Hebei Pukang Medical Instruments Co., Ltd.",2,3,"","","hebei-pukang-medical-instruments-co-ltd-518493-03292017","During an inspection of your firm located in Boading, Heibi, Chinaon January 9, 2017, through January 12, 2017, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures AC-powered adjustable beds, wheeled",0,[9,10,11,12,17,18,20],"3007744192","",""],["2017-03-29","Targeted Medical Pharma, Inc. dba Physician Therapeutics",0,3,"","","targeted-medical-pharma-inc-dba-physician-therapeutics-510913-03292017","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between June 14, 2016, and July 1, 2016. Ms. Diane C. Van Leeuwen, representing FDA, conducted an",0,[],"3004215358","",""],["2017-03-27","Indoco Remedies Limited",0,3,"","","indoco-remedies-limited-514601-03272017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Indoco Remedies Limited, Plants II & III, L-32, 33, 34 Verna Industrial Estate Area, Verna, Goa, from August 31 to September 4, 2016. This warning letter summarizes signifi",0,[1,2,3,10,14,18],"3005124189","",""],["2017-03-23","X12 Co., LTD.",2,3,"","","x12-co-ltd-518581-03232017","During an inspection of your firm located in Sofia, Bulgaria on September 5, 2016, through September 7, 2016, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures sterile reflective marker spheres. Un",0,[2,9,10,11,13,18],"3009222666","",""],["2017-03-20","Merrill D. Benson, M.D.",0,3,"","","merrill-d-benson-md-518882-03202017","This Warning Letter informs you of objectionable conditions observed during the Food and Drug Administration (FDA) inspection conducted at your clinical site between October 11, 2016, and November 10, 2016. Ms. Myra K. Casey, Mr. Lewis K. Antwi, and Ms. Melani",0,[],"3012828918","",""],["2017-03-16","Opto-Pharm Pte Ltd.",0,3,"","","opto-pharm-pte-ltd-517254-03162017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Opto-Pharm Pte Ltd. at 13, Tuas Avenue 12, Singapore, from March 14 to 22, 2016. This warning letter summarizes significant violations of current good manufacturing practic",0,[1,2,4,6,10,13,16,18],"3005320466","",""],["2017-03-10","USV Limited",0,3,"","Mr. Prashant K. Tewari","usv-limited-510159-03102017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, USV Private Limited at H-17/H-18, OIDC, Mahatma Gandhi Udyog Nagar, Dabhel, Daman from June 1 to 10, 2016. This warning letter summarizes significant violations of current",0,[0,1,2,7,8,14,15,18],"3004086192","",""],["2017-03-07","Ark Bio Medical Canada Corp",1,3,"","","ark-bio-medical-canada-corp-516211-03072017","During an inspection of your firm located at 671 Russtico Road, Route #7, North Milton, Prince Edward Island, Canada, between July 14 and July 17, 2015, an investigator from the United States Food and Drug Administration (FDA) documented that your firm manufac",0,[17,18,20],"3005656725","",""],["2017-03-02","Badrivishal Chemicals & Pharmaceuticals",0,3,"","","badrivishal-chemicals-pharmaceuticals-511820-03022017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Badrivishal Chemicals & Pharmaceuticals at Gat No. 29, Village Jambwade (Induri), Post Sudumbre, Taluka Maval, Dist. Pune, Maharashtra, from August 16 to 19, 2016. This war",0,[0,5,6,7,9,14,18],"3004058356","",""],["2017-03-02","Lumis Global Pharmaceuticals Co. Ltd.",0,3,"","","lumis-global-pharmaceuticals-co-ltd-516043-03022017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Lumis Global Pharmaceuticals Co. Ltd. at Unit 305 Huishang Mansion Building A, 2 Wudayuan Road Donghu New Technology Development Zone, Wuhan, from September 26 to 28, 2016.",0,[14,17,18,21],"3010280514","",""],["2017-02-24","Jinan Jinda Pharmaceutical Chemistry Co., Ltd.",0,3,"","","jinan-jinda-pharmaceutical-chemistry-co-ltd-509618-02242017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Jinan Jinda Pharmaceutical Chemistry Co., Ltd. at No. 6121 Longquan Road, Zhangqiu City (Jinan), Shandong Province, from May 30 to June 1, 2016. This warning letter summari",0,[0,6,7,14,18],"3004002973","",""],["2017-02-24","Megafine Pharma (P) Limited",0,3,"","","megafine-pharma-p-limited-510862-02242017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Megafine Pharma (P) Ltd. at Plot No. 911 & 912, GIDC, Phase III, Vapi, Gujarat State, from September 19\u201323, 2016. This warning letter summarizes significant deviations from",0,[0,3,6,14,18],"3006688078","",""],["2017-02-23","G L E Gesellschaft Fur Lichttechnische Erzeugnisse Mbh",2,3,"","","g-l-e-gesellschaft-fur-lichttechnische-erzeugnisse-mbh-508514-02232017","During an inspection of your firm located in Berlin, Germany on July 25, 2016, through July 29, 2016, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures sunlamp products and ultraviolet lamps. Under",0,[9,10,11,12,18,20],"3002553648","",""],["2017-02-14","Chongqing Pharma Research Institute Co., Ltd.",0,3,"","","chongqing-pharma-research-institute-co-ltd-515080-02142017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Chongqing Pharma Research Institute Co., Ltd. at No. 565 Tushan Road, Nanan District, Chongqing, from May 16\u201319, 2016. This warning letter summarizes significant deviations",0,[0,5,6,7,18],"3011903543","",""],["2017-02-03","Resonance Laboratories Private Limited",0,3,"","Tushar B. Gore","resonance-laboratories-private-limited-511907-02032017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Resonance Laboratories Private Limited at No. 8C & 9A, KIADB Industrial Area, Bashettihalli, Doddaballapur, Bangalore, from May 2 to 6, 2016. This warning letter summarizes",0,[2,3,18],"3004483648","",""],["2017-02-02","Sato Pharmaceutical Co., Ltd.",0,3,"","Yoshinori Ito","sato-pharmaceutical-co-ltd-511905-02022017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Sato Pharmaceutical Co., Ltd. at 1468 Hazamamachi, Hachioji, Tokyo, from February 8 to 12, 2016. This warning letter summarizes significant violations of current good manuf",0,[1,2,8,18],"3004055563","",""],["2017-01-31","Ausmetics Daily Chemicals (Guangzhou) Co., Ltd",0,3,"","Jacky Lau","ausmetics-daily-chemicals-guangzhou-co-ltd-510934-01312017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Ausmetics Daily Chemicals (Guangzhou) Co., Ltd. at NO. 1 Jinxiu Road, Economic and Technical Development District, Guangzhou, Guangdong from July 25\u201329, 2016. This warning",0,[6,15,18],"3005063169","",""],["2017-01-27","Cassandra E. Curtis, M.D.",0,3,"","","cassandra-e-curtis-md-520266-01272017","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between August 15, 2016, and September 14, 2016. Ms. Corrine Carter, Ms. Myra Casey, and Ms. Mela",0,[],"","",""],["2017-01-26","Zhejiang Bangli Medical Products Co., Ltd",0,3,"","Mr. Zheng Guo Li","zhejiang-bangli-medical-products-co-ltd-510524-01262017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Zhejiang Bangli Medical Products Co., Ltd. at South of YueGui Road 118, Huachuan Block, Yongkang City, from August 16 to 17, 2016. This warning letter summarizes significan",0,[3,18],"3007028032","",""],["2017-01-18","CTX Lifesciences Private Ltd.",0,3,"","Mr. Kanak J. Jariwala","ctx-lifesciences-private-ltd-496393-01182017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, CTX Life Sciences Private Ltd. (CTX), at Block No: 251/P, 252/P, GIDC, Sachin-Magdalla Road, Surat, Gujarat, from February 15\u201319, 2016. This warning letter summarizes signi",0,[3,5,10,14,18],"3006254924","",""],["2017-01-17","Porton Biopharma Limited",0,3,"","Dr. Roger J. Hinton","porton-biopharma-limited-509689-01172017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Porton Biopharma, Limited (formerly known as Public Health England), at Manor Farm Road, Porton Down, Salisbury, from March 7 to 18, 2016. This warning letter summarizes si",0,[1,2,8,9,14,15,18],"3011691465","",""],["2017-01-13","FACTA Farmaceutici S.p.A.",0,3,"","Mr. Carlo Vergani","facta-farmaceutici-spa-495986-01132017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, FACTA Farmaceutici S.p.A at Zona Industriale Sant Atto, San Nicolo a Tordino, Teramo 64100, from January 11 to 19, 2016. This warning letter reviews significant violations",0,[0,6,7,8,14,18],"3006028606","",""],["2017-01-06","Cixi Zhixin Bird Clean-Care Product Co., Ltd.",0,3,"","Mr. Rujun Sun","cixi-zhixin-bird-clean-care-product-co-ltd-510181-01062017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility Ningbo Zhixin Bird Clean-Care Product Company, Ltd. (also known as Cixi Zhixin Bird Clean-Care Product Company, Ltd.), at 137 Bali Road, Zhangqi Town, Cixi City, Zhejiang, f",0,[3,4,6,14,15,18],"3008077936","",""],["2017-01-06","Sato Yakuhin Kogyo Co., Ltd.",0,3,"","Mr. Susumu Sato","sato-yakuhin-kogyo-co-ltd-512711-01062017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Sato Kogyo Co., Ltd. at 9-2, Kannonji-Cho, Kashihara City, Nara Prefecture, from June 6 to 10, 2016. This warning letter summarizes significant violations of current good m",0,[0,3,5,6,7,14,18],"3003183265","",""],["2017-01-06","Suzhou Pharmaceutical Technology Co.,Ltd",0,3,"","Mr. Michael Lu","suzhou-pharmaceutical-technology-coltd-508490-01062017","The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Suzhou Pharmaceutical Technology Co., Ltd at #3 Tongjing Commercial Plaza, Room 920, Jifeng Road, Suzhou, from June 6 to 8, 2016. This warning letter summarizes significant",0,[14,18],"3010679196","",""],["2017-01-05","Kang Zhang, M.D., Ph.D.",0,3,"","","kang-zhang-md-phd-511374-01052017","This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between July 14, 2016, and August 1, 2016. Ms. Natalie J. Ayoub, representing FDA, reviewed your",0,[],"3012242764","",""],["2015-08-11","Dexcowin Co. Ltd.",2,2,"","Raymond Ryu","dexcowin-co-ltd-474468-08112015","During an inspection of your firm located in Seoul, Republic of South Korea on March 23 2015 through March 26 2015, an investigator (or investigators) from the United States Food and Drug Administration (FDA) determined that your firm manufactures Dental Diagn",0,[10,11,18,20],"3007065358","",""]]}