Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
FDA establishment 1210580, Lincoln, Rhode Island, United States. Part of Denison Pharmaceuticals's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 6
Official action indicated: 2
Last inspection ended: Jul 29, 2024
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 2 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 211.56(a). Sanitation--buildings not clean, free of infestation Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition and free of infestation by rodents, birds insects, and other vermin.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
21 CFR 211.42(a). Buildings of Suitable Size, Construction, Location Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.
21 CFR 211.101(d). Component addition checked by 2nd person Each component is not added to a batch by one person and verified by a second person.
21 CFR 211.182. Written records kept in individual logs Written records of major equipment cleaning are not included in individual equipment logs.
21 CFR 211.100(a). Absence of Written Procedures Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
21 CFR 211.192. Quality control unit review of records Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
21 CFR 211.122(d). Label storage access limited to authorized personnel Access to the storage area for labels and labeling materials is not limited to authorized personnel.
21 CFR 211.125(a). Strict control not exercised over labeling issued Strict control is not exercised over labeling issued for use in drug product labeling operations.
Official Action Indicated (OAI)
Feb 9, 2023
Drugs · Drug Quality Assurance
9 cited references
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
21 CFR 211.165(e). Test methods The accuracy, sensitivity, specificity and reproducibility of test methods have not been established.
21 CFR 211.84(d)(1). Component identity verification Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed.
21 CFR 211.94(b). Protection from external factors Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.
21 CFR 211.100(a). Absence of Written Procedures Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
21 CFR 211.28(b). Habits of good sanitation & health Production personnel were not practicing good sanitation and health habits.
21 CFR 211.113(a). Procedures for non-sterile drug products Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established, written and followed.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Official Action Indicated (OAI)
Apr 5, 2016
Drugs · Postmarket Surv. and EpidemiologyDrugs · Unapproved and Misbranded Drugs; Drugs · Drug Quality Assurance
8 cited references
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
21 CFR 211.194(a)(4). Data secured in course of each test Laboratory records do not include a complete record of all data secured in the course of each test, including all graphs , charts and spectra from laboratory instrumentation, properly identified to show the specific component , drug product container , in-process material , lot tested and drug product tested.
21 CFR 211.165(e). Test methods The accuracy , sensitivity , specificity and reproducibility of test methods have not been established and documented.
21 CFR 211.58. Buildings not maintained in good state of repair Buildings used in the manufacturing , processing , packing and holding of a drug product are not maintained in a good state of repair.
21 CFR 211.25(a). GMP Training Frequency GMP training is not conducted on a continuing basis to assure that employees remain familiar with CGMP requirements applicable to them.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not fully followed.
21 CFR 211.68(b). Computer control of master formula records Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
21 CFR 211.160(a). Lab controls established, including changes The establishment of specifications , standards , sampling plans , test procedures and laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit and reviewed and approved by the quality control unit.
No Action Indicated (NAI)
Mar 15, 2013
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Oct 7, 2010
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Aug 5, 2009
Drugs · Drug Quality Assurance
6 cited references
21 CFR 211.180(e)(1). Review of representative number of batches Written procedures are not followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not fully followed.
21 CFR 211.198(a). Procedures to be written and followed Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.
21 CFR 211.58. Buildings not maintained in good state of repair Buildings used in the holding of a drug product are not maintained in a good state of repair.
21 CFR 211.25(a). Training--operations, GMPs, written procedures Employees are not given training in the particular operations they perform as part of their function.
21 CFR 211.67(b). Written procedures not established/followed Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard and warning letters
Lincoln, Rhode Island, United States. Part of