21 CFR 211.84(d)(2). Component written specification Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
21 CFR 211.67(b)(3). Cleaning SOPs/instructions Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.
21 CFR 211.192. Written record of investigation incomplete Written records of investigations into unexplained discrepancies do not include the conclusions and follow-up.
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test procedures designed to assure that components, in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.166(a). Results not used for expiration dates, storage cond. Results of stability testing are not used in determining appropriate storage conditions and expiration dates.
Official Action Indicated (OAI)
Mar 26, 2025
Drugs · Drug Quality Assurance
5 cited references
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, sampling plans and test procedures designed to assure that components, in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.22(a). Lack of quality control unit There is no quality control unit.
21 CFR 211.67(b)(3). Cleaning SOPs/instructions Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.
21 CFR 211.84(d)(2). Component written specification Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
21 CFR 211.166(a). Results not used for expiration dates, storage cond. Results of stability testing are not used in determining expiration dates.
Official Action Indicated (OAI)
Feb 17, 2023
Drugs · Drug Quality Assurance
7 cited references
21 CFR 211.84(d)(2). Reports of Analysis (Components) Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component and establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.180(e)(2). Items to cover on annual reviews Written procedures are not established and followed for evaluations done at least annually and including provisions for a review of complaints, recalls and returned or salvaged drug products.
21 CFR 211.194(a)(1). Description and Identification of Samples Laboratory records are deficient in that they do not include a description and identification of the sample received and lot number.
21 CFR 211.100(a). Approval and review of procedures Written procedures are not drafted, reviewed and approved by the appropriate organizational units and reviewed and approved by the quality control unit.
21 CFR 211.165(f). Failing drug products not rejected Drug products failing to meet established specifications and quality control criteria are not rejected.
21 CFR 211.166(a). Lack of written stability program There is no written testing program designed to assess the stability characteristics of drug products.
21 CFR 820.90(a). Nonconforming product, Lack of or inadequate procedures Procedures have not been adequately established to control product that does not conform to specified requirements.
21 CFR 820.181. DMR - not or inadequately maintained A device master record has not been maintained.
Voluntary Action Indicated (VAI)
Mar 10, 2011
Drugs · Drug Quality Assurance
3 cited references
21 CFR 211.198(a). Quality Control Review Complaint procedures are deficient in that they do not include provisions that allow for the review and determination of an investigation by the quality control unit.
21 CFR 211.25(a). GMP Training Frequency GMP training is not conducted on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
21 CFR 211.180(e)(2). Items to cover on annual reviews Written procedures are not established and followed for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products, and investigations conducted for each drug product.
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