21 CFR 211.84(d)(1). Identity Testing of Each Component The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.
Voluntary Action Indicated (VAI)
Sep 1, 2023
Drugs · Drug Quality Assurance
5 cited references
21 CFR 211.115(b). Reprocessing/quality control unit Reprocessing was performed without the review and approval of the quality control unit.
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 211.192. No written record of investigation Written records are not always made of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications.
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and standards designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.100(a). Absence of Written Procedures Your firm failed to establish 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.
Voluntary Action Indicated (VAI)
Jun 13, 2018
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Jun 8, 2015
Drugs · Drug Quality AssuranceDrugs · Unapproved and Misbranded Drugs
None posted
Voluntary Action Indicated (VAI)
Jan 3, 2013
Drugs · Drug Quality Assurance
13 cited references
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
21 CFR 211.111. Establishment of time limitations Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
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 and location to facilitate cleaning, maintenance, and proper operations.
21 CFR 211.25(a). Training--operations, GMPs, written procedures Employees are not given training in current good manufacturing practices and written procedures required by current good manufacturing practice regulations.
21 CFR 211.166(a). Written program not followed The written stability testing program is not followed.
21 CFR 211.165(f). Failing drug products not rejected Drug products failing to meet established standards, specifications, and quality control criteria are not rejected.
21 CFR 211.165(e). Test methods The accuracy, sensitivity, specificity, and reproducibility of test methods have not been established and documented.
21 CFR 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
21 CFR 211.165(b). Microbiological testing Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
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 211.192. 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 211.180(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 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
Voluntary Action Indicated (VAI)
Jul 13, 2009
Drugs · Drug Quality AssuranceDrugs · Unapproved and Misbranded Drugs
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