{"generated":"2026-11-08","through":"2026-10-20","firstYear":2009,"lastYear":2027,"products":["Drugs","Devices","Biologics"],"inspections":{"Drugs":{"us":[421,574,586,587,461,392,412,429,390,410,402,172,183,289,253,324,505,331,0],"x":[11,11,31,59,59,89,105,119,179,166,175,77,2,60,126,140,131,48,0]},"Devices":{"us":[616,764,796,891,840,735,682,632,700,697,660,339,181,454,480,432,567,510,10],"x":[44,100,143,176,193,186,264,178,168,128,68,51,0,27,173,133,148,58,0]},"Biologics":{"us":[190,243,226,238,180,136,124,81,109,86,113,25,16,60,40,47,105,69,0],"x":[3,1,1,0,2,3,0,3,3,1,2,2,0,0,3,1,2,2,0]}},"rows":[{"c":"21 CFR 211.192","d":"Investigations of discrepancies, failures","p":0,"us":[121,156,183,146,132,96,121,122,87,98,111,57,69,97,72,76,158,107,0],"x":[4,1,14,11,23,31,25,40,51,47,63,29,1,21,49,60,49,24,0],"o":[693,2401],"e":[["Baxter Healthcare Corporation","US","2026-09-23","2649614"],["ACTA Laboratories, Inc.","US","2026-09-04","1000125694"],["Microbac Laboratories, Inc.","US","2026-09-03","1021259"],["Steril-Gene Life Sciences Private Ltd","IN","2026-08-12","3014319211"]]},{"c":"21 CFR 211.22(d)","d":"Procedures not in writing, fully followed","p":0,"us":[119,129,157,130,107,73,104,87,104,124,102,54,67,101,91,119,175,106,0],"x":[3,0,6,14,18,28,24,25,55,44,62,25,1,22,24,52,46,15,0],"o":[569,2282],"e":[["Baxter Healthcare Corporation","US","2026-09-23","2649614"],["PD-Rx Pharmaceuticals, Inc.","US","2026-08-20","1641825"],["AVEVA Drug Delivery Systems, Inc.","US","2026-08-14","1000307689"],["A-S Medication Solutions LLC","US","2026-08-12","1450743"]]},{"c":"21 CFR 211.100(a)","d":"Absence of Written Procedures","p":0,"us":[92,115,129,121,90,61,63,73,66,55,67,33,42,66,50,79,120,59,0],"x":[1,1,6,13,9,18,22,19,35,28,31,13,0,17,26,37,34,12,0],"o":[526,1587],"e":[["USpharma, Ltd., Co.","US","2026-09-03","1010370"],["PD-Rx Pharmaceuticals, Inc.","US","2026-08-20","1641825"],["A-S Medication Solutions LLC","US","2026-08-12","1450743"],["Steril-Gene Life Sciences Private Ltd","IN","2026-08-12","3014319211"]]},{"c":"21 CFR 211.160(b)","d":"Scientifically sound laboratory controls","p":0,"us":[63,68,84,81,58,53,62,59,56,64,57,26,38,56,40,56,78,60,0],"x":[2,2,8,10,12,21,33,39,42,33,48,16,0,12,23,42,34,13,0],"o":[433,1382],"e":[["AptaPharma Inc.","US","2026-08-14","3010164738"],["Steril-Gene Life Sciences Private Ltd","IN","2026-08-12","3014319211"],["Fuller Industries Inc","US","2026-07-23","1922337"],["Biochemical and Scientific Consultants cc","ZA","2026-07-20","3013131635"]]},{"c":"21 CFR 211.25(a)","d":"Training--operations, GMPs, written procedures","p":0,"us":[85,131,144,140,75,66,64,61,61,60,63,25,38,28,20,38,52,21,0],"x":[0,2,2,9,10,11,15,14,33,32,20,6,2,5,14,12,10,3,0],"o":[303,1273],"e":[["Neilmed Pharmaceuticals Inc","US","2026-07-22","3002998723"],["Boiron Inc.","US","2026-06-26","2510831"],["Biokosmes Srl","IT","2026-06-26","3005488444"],["Scinopharm Taiwan, Ltd.","TW","2026-06-23","3002840477"]]},{"c":"21 CFR 211.67(b)","d":"Written procedures not established/followed","p":0,"us":[69,82,89,81,72,56,48,43,44,45,48,19,18,32,26,41,59,46,0],"x":[3,3,3,11,9,15,11,21,24,22,25,8,0,2,8,17,8,2,0],"o":[267,1034],"e":[["Neilmed Pharmaceuticals Inc","US","2026-07-22","3002998723"],["I. 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Shay Cosmetics Inc","US","2026-07-17","3002757783"]]},{"c":"21 CFR 211.63","d":"Equipment Design, Size and Location","p":0,"us":[32,38,36,38,32,20,29,24,22,25,28,18,18,31,31,49,56,25,0],"x":[0,1,3,5,1,3,4,9,10,14,17,13,0,12,16,22,12,4,0],"o":[238,663],"e":[["Episciences Inc","US","2026-07-31","3006435842"],["Biochemical and Scientific Consultants cc","ZA","2026-07-20","3013131635"],["Advanced Cosmetic Research Laboratories, Inc.","US","2026-06-26","3003059934"],["My CHS Rx, Inc.","US","2026-06-05","3033529550"]]},{"c":"21 CFR 211.160(a)","d":"Following/documenting laboratory controls","p":0,"us":[26,44,50,45,32,24,27,36,35,32,28,14,15,16,11,12,19,16,0],"x":[2,1,4,7,5,11,23,20,19,15,21,9,0,7,16,16,5,2,0],"o":[146,618],"e":[["Canyon Rush, LLC","US","2026-05-15","1316257"],["Sombra Cosmetics, Inc","US","2026-05-08","1629960"],["Samson Pharmaceuticals, Inc","US","2026-04-29","3005644727"],["Hanlim Pharm Co. 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Shay Cosmetics Inc","US","2026-07-17","3002757783"],["Topical Pharmaceuticals, Inc.","US","2026-05-07","3005402103"],["Best Sanitizers Inc","US","2026-05-01","3005763425"],["MD Logistics, LLC","US","2026-04-03","3004026589"]]},{"c":"21 CFR 211.80(a)","d":"Procedures To Be in Writing","p":0,"us":[38,47,53,37,24,18,20,18,21,16,17,6,6,9,5,6,6,7,0],"x":[2,0,2,3,4,3,5,4,7,5,7,2,0,4,1,1,1,1,0],"o":[94,374],"e":[["Steril-Gene Life Sciences Private Ltd","IN","2026-08-12","3014319211"],["The Flower Remedy LLC","US","2026-06-12","3017764186"],["GVS TM, Inc","US","2026-05-01","2013342"],["Cosmetic Lab, Inc.","US","2026-03-10","3011959287"]]},{"c":"21 CFR 211.165(e)","d":"Test methods","p":0,"us":[15,27,28,24,19,14,15,18,20,14,19,7,8,15,13,10,14,4,0],"x":[1,1,1,6,6,2,7,11,22,9,17,4,0,2,9,8,7,4,0],"o":[131,379],"e":[["Nowcos Co., Ltd.","","2026-06-19","3009968674"],["Product Society LLC","US","2026-06-12","3023272193"],["Allure Labs, LLC","US","2026-03-27","3000204079"],["Dr. J Skinclinic, Inc","US","2026-03-23","3006185812"]]},{"c":"21 CFR 211.170(b)","d":"Annual visual exams of drug products","p":0,"us":[19,26,23,19,34,14,13,10,15,18,11,2,14,8,8,11,15,8,0],"x":[0,0,1,6,4,7,12,10,10,14,16,5,0,5,4,4,5,2,0],"o":[92,357],"e":[["Conopco Inc. d/b/a Unilever","US","2026-07-13","1047784"],["Advagen Holdings, Inc.","US","2026-05-13","3009964119"],["KDC/ONE SOCAL LABORATORIES, LLC","US","2026-04-14","3021082665"],["Deciem Inc.","CA","2026-04-02","3014275940"]]},{"c":"21 CFR 211.84(d)(1)","d":"Identity Testing of Each Component","p":0,"us":[18,15,23,23,20,10,14,16,20,12,10,3,3,12,21,31,30,24,0],"x":[0,0,1,2,1,2,8,1,7,4,8,2,0,1,5,9,11,4,0],"o":[130,337],"e":[["Noven Pharmaceuticals, Inc.","US","2026-08-24","1000222037"],["AVEVA Drug Delivery Systems, Inc.","US","2026-08-14","1000307689"],["Steril-Gene Life Sciences Private Ltd","IN","2026-08-12","3014319211"],["Aizant Drug Research Solutions Private Ltd.","IN","2026-07-31","3008243902"]]},{"c":"21 CFR 211.194(a)","d":"Complete test data included in records","p":0,"us":[11,19,15,21,14,12,13,12,15,15,11,3,10,6,3,3,10,7,0],"x":[1,1,2,7,4,7,10,12,18,11,14,8,1,2,9,15,4,4,0],"o":[103,309],"e":[["Steril-Gene Life Sciences Private Ltd","IN","2026-08-12","3014319211"],["Bushu Pharmaceuticals Ltd.","JP","2026-08-03","3005709762"],["Pace Analytical Life Sciences, LLC","US","2026-05-29","3001452367"],["Canyon Rush, LLC","US","2026-05-15","1316257"]]},{"c":"21 CFR 211.113(a)","d":"Procedures for non-sterile drug products","p":0,"us":[19,10,24,20,18,9,9,17,16,19,16,4,10,17,11,15,16,11,0],"x":[0,0,3,4,1,4,4,9,10,6,5,2,0,2,5,6,3,3,0],"o":[96,313],"e":[["S.s.s. 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Griffen Company","US","2025-05-16","1211177"]]},{"c":"21 CFR 211.160(b)(1)","d":"Incoming lots - conformance to written specs-","p":0,"us":[8,7,10,5,6,3,5,3,1,3,5,1,2,2,1,0,1,0,0],"x":[0,0,0,1,0,2,5,3,5,3,3,3,0,0,5,2,0,1,0],"o":[28,91],"e":[["Similasan AG","CH","2026-04-27","1000110034"],["Noble Panacea Labs, Inc.","US","2024-11-08","3027485555"],["International Laboratories Corp., Limited","TH","2024-09-20","3006403166"],["Landy International","CN","2023-12-14","3005698871"]]},{"c":"21 CFR 211.67(b)(3)","d":"Cleaning SOPs/instructions","p":0,"us":[4,2,1,1,0,2,1,5,1,6,8,2,6,6,5,7,16,5,0],"x":[0,1,0,0,0,0,0,2,2,1,1,0,0,2,2,6,1,0,0],"o":[39,89],"e":[["Fuller Industries Inc","US","2026-07-23","1922337"],["LifeSouth Community Blood Centers, Inc","US","2026-05-21","3003707120"],["Happy Farm Botanicals, Inc.","US","2026-04-02","3011407349"],["Identipak Inc","US","2025-12-18","3002422294"]]},{"c":"21 CFR 211.80(d)","d":"Status of Each Lot 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Braun US Pharmaceutical Manufacturing LLC","US","2025-01-31","3014200891"],["Future Foam, Inc.","US","2024-09-27","3004758248"]]},{"c":"21 CFR 211.188(a)","d":"Accurate reproduction","p":0,"us":[3,8,4,3,1,0,2,5,8,5,6,1,2,4,4,1,3,0,0],"x":[0,0,0,1,0,0,1,2,4,1,0,2,0,0,0,1,0,0,0],"o":[20,68],"e":[["Winder Laboratories, LLC","US","2025-08-05","3008694072"],["Delicate Cosmetics, Inc.","US","2025-06-27","3009081371"],["Quest Products LLC","US","2024-11-07","3007802698"],["Aerosol and Liquid Packaging, Inc.","US","2023-12-18","1120890"]]},{"c":"21 CFR 211.196","d":"Distribution Record Requirements","p":0,"us":[9,0,5,13,4,4,3,7,2,4,2,1,1,3,1,5,2,1,0],"x":[0,0,0,1,0,0,0,1,2,0,0,0,0,0,0,1,0,0,0],"o":[29,68],"e":[["Mountainside Medical Equipment, Inc.","US","2026-08-12","3006695043"],["Sani-Care Salon Products, Inc","US","2025-01-17","3014759234"],["Cosco International, Inc.","US","2024-10-25","3000220439"],["EnviroServe Chemicals Inc.","US","2024-09-17","3016841297"]]},{"c":"21 CFR 211.42(c)(10)","d":"Aseptic Processing Area","p":0,"us":[0,2,1,0,6,5,6,8,2,6,5,3,0,4,0,2,1,2,0],"x":[0,0,0,1,0,1,2,1,0,4,3,2,0,1,1,1,0,2,0],"o":[48,71],"e":[["Hetero Labs Ltd. 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Sweet, MD","US","2025-11-21","3040979765"],["Edmundowicz, Dr Steven","US","2025-10-09","3011025947"]]},{"c":"21 CFR 820.20(a)","d":"Quality policy and objectives","p":1,"us":[22,33,21,19,10,11,10,4,9,3,7,3,3,7,4,7,7,0,0],"x":[0,2,1,2,3,0,1,1,0,0,1,1,0,0,0,1,0,0,0],"o":[59,193],"e":[["VirtuSense Technologies, Inc.","US","2025-09-18","3023132085"],["Trident Manufacturing, Inc.","US","2025-08-28","3008717566"],["Magnatone Hearing Aid Corp","US","2025-07-14","1044692"],["Pointcore Supply Chain Service LLC","US","2025-06-26","3024510438"]]},{"c":"21 CFR 820.30(d)","d":"Design output - Lack of or inadequate procedures","p":1,"us":[13,9,15,13,10,7,10,12,7,5,9,4,5,5,2,7,6,1,0],"x":[1,0,3,4,2,5,2,4,0,3,0,2,0,0,4,4,1,0,0],"o":[42,175],"e":[["KSL Biomedical, Inc.","US","2025-10-24","3017505309"],["DGI Group LLC","US","2025-08-19","3014527929"],["Blue Elephant Inc","US","2025-05-16","3031025053"],["Vayuclear Inc","US","2025-03-14","3030977779"]]},{"c":"21 CFR 820.250(a)","d":"Statistical techniques - 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Hicks, M.D.","US","2024-09-12","3031511465"]]},{"c":"21 CFR 820.20(b)(3)","d":"Management representative","p":1,"us":[12,18,0,0,0,0,2,0,0,2,4,6,4,6,6,11,8,2,0],"x":[0,1,0,0,0,0,0,0,0,0,0,0,0,0,0,1,1,0,0],"o":[13,84],"e":[["Drake Precision Dental Laboratory","US","2025-11-05","3002706372"],["SPOT HEALTH INC","US","2025-10-22","3026940910"],["Pointcore Supply Chain Service LLC","US","2025-06-26","3024510438"],["Radiology Information Systems, Inc.","US","2025-06-18","3002952981"]]},{"c":"21 CFR 820.120(d)","d":"Records, DHR {see also 820.184(e)}","p":1,"us":[4,2,10,4,2,5,3,1,4,4,5,1,1,1,0,2,5,0,0],"x":[1,3,2,5,8,2,3,1,1,1,0,0,0,0,1,1,0,0,0],"o":[19,83],"e":[["R&D Batteries, Inc.","US","2025-08-06","1000140026"],["Microvapor Devices LLC","US","2025-07-18","3011528328"],["Better Water LLC","US","2025-06-26","1000112932"],["Auxilium Medical Inc.","US","2025-03-26","3014650138"]]},{"c":"21 CFR 820.100(a)(3)","d":"Identification of actions 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Medical Inc.","US","2026-09-16","3006342679"],["Opus KSD, Inc.","US","2026-09-03","3011301103"],["EEG Software LLC","US","2026-08-27","3010129717"]]},{"c":"21 CFR 820.180(b)","d":"Retention period","p":1,"us":[2,5,5,2,3,4,0,0,3,2,0,0,0,1,0,0,1,0,0],"x":[1,0,0,0,0,0,0,2,0,1,0,0,0,0,0,1,0,0,0],"o":[9,33],"e":[["Varex Imaging Corporation","US","2025-08-25","1717855"],["Regent Electron (Suzhou) Co., Ltd.","CN","2024-08-15","3012404027"],["Mcminnville Workholding Company, Inc.","US","2022-06-03","3003765982"],["Meditherm Inc.","US","2018-05-30","3006111110"]]},{"c":"ISO 13485:2016 Clause 8.2.4","d":"Internal audits not conducted to ensure QMS meets requirements and is effective","p":1,"us":[0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,29,0],"x":[0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,4,0],"o":[4,33],"e":[["Orthopedic Generations LLC","US","2026-09-25","3012724179"],["Enviropak, LLC","US","2026-09-23","1000132322"],["Metropolis International LLC","US","2026-08-06","3005877899"],["The University of Texas MD Anderson Cancer Center, Department of Radiation Physics, Division of Radiation Oncology","US","2026-07-27","3030564015"]]},{"c":"21 CFR 820.184(e)","d":"ID label, labeling","p":1,"us":[11,4,1,0,0,0,2,0,0,0,0,0,0,0,0,0,0,0,0],"x":[4,5,0,1,2,1,0,0,0,0,0,0,0,0,0,0,0,0,0],"o":[4,31],"e":[["NeuroMetrix, Inc.","US","2015-05-07","3011412151"],["BL Healthcare, Incorporated","US","2015-03-30","3005351361"],["Moeller Medical GmbH","DE","2014-01-30","3002807634"],["Daheng New Epoch Technology, Inc.","CN","2013-07-19","3008705657"]]},{"c":"21 CFR 820.200(b)","d":"Analyzing service report","p":1,"us":[3,1,2,6,5,3,0,1,2,2,1,0,0,2,0,0,0,0,0],"x":[0,1,0,1,0,0,0,1,0,0,0,0,0,0,0,0,0,0,0],"o":[9,31],"e":[["Custom Smiles Sleep Department","US","2022-03-18","3014945982"],["Sunnex, LLC","US","2022-02-18","1000583780"],["Compumedics USA, Inc","US","2019-03-05","3002716534"],["Ushio America, Inc.","US","2018-05-31","1000305716"]]},{"c":"21 CFR 820.72(b)(2)","d":"Calibration documentation","p":1,"us":[14,11,0,0,0,0,1,0,0,0,0,0,0,0,0,0,0,0,0],"x":[0,4,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0],"o":[5,30],"e":[["Hampton Medical Devices, LLC","US","2015-08-12","1937445"],["Andonian Cryogenics, Inc.","US","2010-06-30","1219165"],["Andreas Hettich Gmbh & Co. 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Hartnick, MD","US","2019-06-28","3015376495"]]},{"c":"ISO 13485:2016 Clause 5.6.1","d":"QMS not reviewed by top management at documented planned intervals","p":1,"us":[0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,24,2],"x":[0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,1,0],"o":[2,27],"e":[["Aurident Inc","US","2026-10-15","2023817"],["Tactical Medical Solutions, Thermal Management Group","US","2026-10-14","3009141585"],["Enviropak, LLC","US","2026-09-23","1000132322"],["Vitalcor, Inc.","US","2026-08-14","1450019"]]},{"c":"ISO 13485:2016 Clause 7.4.3","d":"Purchased product verification activities not established or implemented","p":1,"us":[0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,27,0],"x":[0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0],"o":[1,27],"e":[["FKA Distributing Co., LLC","US","2026-09-01","1832894"],["Neurotron, Inc.","US","2026-08-21","1121806"],["ECLOSION","US","2026-08-13","3030198312"],["Superior Labs Inc","US","2026-08-11","3034286079"]]},{"c":"21 CFR 820.100(a)(5)","d":"Changes to correct/prevent quality problems","p":1,"us":[13,6,0,0,0,0,1,0,0,0,0,0,0,0,0,0,0,0,0],"x":[1,2,0,1,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0],"o":[4,24],"e":[["Madison Polymeric Engineering","US","2015-03-23","3001451466"],["Podo Xingda Medical Co., Ltd.","CN","2012-08-16","3007363456"],["Baxter Healthcare Corporation","US","2010-03-29","1417572"],["Etymotic Research, Inc.","US","2010-03-02","1450042"]]},{"c":"21 CFR 820.150(a)","d":"Storage procedures to prevent mix-ups","p":1,"us":[12,8,0,1,0,0,2,0,0,0,0,0,0,0,0,0,0,0,0],"x":[1,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0],"o":[8,24],"e":[["Commonwealth Diagnostics International Inc.","US","2015-06-25","3009236726"],["Medsource, Inc.","US","2015-03-31","3003929882"],["Lonza Walkersville, Inc.","US","2011-12-02","1114298"],["Dynamic Surgery, Inc.","US","2010-05-14","1000513707"]]},{"c":"21 CFR 812.140(b)(1)","d":"Sponsor correspondence records inadequate","p":1,"us":[1,4,4,1,1,2,2,2,0,2,1,0,0,0,0,0,0,1,0],"x":[0,0,0,0,0,0,0,1,0,0,0,0,0,0,0,0,0,0,0],"o":[7,22],"e":[["Vascular Solutions, LLC (A Subsidiary of Teleflex)","US","2025-10-10","3002827704"],["Boston Scientific Corporation","US","2018-11-16","3002095335"],["Coloplast Manufacturing US, LLC","US","2018-09-25","2125050"],["Premier Clinical Research LLC","US","2017-11-29","3011321193"]]},{"c":"21 CFR 812.140(d)","d":"Record retention inadequate","p":1,"us":[0,2,1,3,3,3,3,0,1,2,0,1,0,0,1,0,1,0,0],"x":[0,0,0,0,0,1,0,0,0,0,0,0,0,0,0,0,0,0,0],"o":[7,22],"e":[["Deborah A. 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Miller, MD","US","2026-02-13","3042247790"],["Thomas Sutton, MD","US","2018-05-07","3014378752"],["John Meadors","US","2018-05-07","3009093259"],["Michael J. Pelekanos, MD","US","2017-11-28","3013783260"]]},{"c":"21 CFR 812.25(e)","d":"Sponsor's lack of written monitoring procedures","p":1,"us":[2,1,2,3,0,2,2,0,3,1,1,1,0,0,0,0,1,0,0],"x":[0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0],"o":[8,19],"e":[["Happy Health Inc","US","2025-05-29","3038012445"],["Kennedy, Philip R.","US","2019-10-16","3007184242"],["Christopher J. 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documented",124],["ISO 13485:2016 Clause 8.5.2","Corrective action procedures not documented",96],["ISO 13485:2016 Clause 8.2.2","Complaint handling procedures not documented",91],["ISO 13485:2016 Clause 7.4.1","Criteria for the evaluation and selection of suppliers not established",74],["ISO 13485:2016 Clause 7.5.6","Process for production and service provision not validated",59],["ISO 13485:2016 Clause 8.3.1","Procedure for nonconforming product not documented",49],["ISO 13485:2016 Clause 4.1.2","Risk-based approach not applied to QMS processes",44],["ISO 13485:2016 Clause 7.3.9","Procedures to control design and development changes not documented",38],["ISO 13485:2016 Clause 7.5.1","Production controls not adequate",36],["ISO 13485:2016 Clause 4.1.5","Inadequate monitoring and control over outsourced processes",34],["21 CFR 803.17","Lack of Written MDR Procedures",33],["ISO 13485:2016 Clause 8.2.4","Internal audits not conducted to ensure QMS meets requirements and is effective",33]]}}