| Dec 22, 2025 | Drugs · Drug Quality Assurance | 12 cited references- 21 CFR 211.166(b). Adequate number of batches on stability An adequate number of batches of each drug product are not tested nor are records of such data maintained to determine an appropriate expiration date.
- 21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate standards and sampling plans designed to assure that conform to appropriate standards of identity, strength, quality and purity.
- 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 211.84(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 211.192. Extent of discrepancy, failure investigations Investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
- 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 211.142. Written warehousing procedures established/followed Procedures describing the warehousing of drug products are not followed.
- 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 and written.
- 21 CFR 211.84(d)(2). Establish reliability of supplier's C of A Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
- 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 211.63. Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.
- 21 CFR 211.165(a). Testing and release for distribution Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.
| Official Action Indicated (OAI) |
| Dec 15, 2023 | Drugs · Drug Quality Assurance | 4 cited references- 21 CFR 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which monitor the output and 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 211.22(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 211.142(b). Storage under appropriate conditions Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected.
- 21 CFR 211.63. Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.
| Official Action Indicated (OAI) |
| Aug 24, 2021 | Drugs · Over-the-Counter Drug EvaluationDrugs · Drug Quality Assurance | 12 cited references- 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.
- 21 CFR 211.42(b). Adequate space lacking to prevent mix-ups and contamination The building lacks adequate space for the orderly placement of equipment and materials to prevent mix-ups between drug product containers, in-process materials and drug products and to prevent contamination.
- 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. Electronic records are used, but they do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
- 21 CFR 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which monitor the output and 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 211.22(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 211.142(b). Storage under appropriate conditions Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected.
- 21 CFR 211.25(b). Supervisor Training/Education/Experience Individuals responsible for supervising the manufacture, processing, packing and holding of a drug product lack the training and experience to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality and purity that it purports or is represented to possess.
- 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 211.113(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 211.63. Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design and suitably located to facilitate operations for its intended use and cleaning and maintenance.
- 21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, 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 211.170(b). Annual visual exams of drug products Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
| Official Action Indicated (OAI) |
| Mar 24, 2016 | Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices | None posted | No Action Indicated (NAI) |
| Nov 16, 2015 | Drugs · Drug Quality Assurance | 11 cited references- 21 CFR 211.63. Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.
- 21 CFR 211.198(a). Complaint Handling Procedure Procedures describing the handling of written and oral complaints related to drug products are deficiently written or 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 211.100(a). Absence of Written Procedures There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
- 21 CFR 211.180(e)(1). Review of representative number of batches Written procedures are not established for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
- 21 CFR 211.170(b). Annual visual exams of drug products Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
- 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 211.122(a). Written procedures describing in detail There is a lack of written procedures describing in sufficient detail the receipt, identification, storage, and handling of labeling and packaging materials.
- 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 211.103. Actual vs. theoretical yields not determined Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of manufacturing, processing, packaging, and holding of the drug product.
- 21 CFR 211.160(b)(4). Calibration - at intervals, written program, remedial action The calibration of gauges is not done at suitable intervals with provisions for remedial action in the event accuracy and/or precision limits are not met.
| Voluntary Action Indicated (VAI) |
| Apr 26, 2013 | Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices | None posted | Voluntary Action Indicated (VAI) |
| Jul 23, 2012 | Drugs · Drug Quality Assurance | 13 cited references- 21 CFR 211.188. Prepared for each batch, include complete information Batch production and control records do not include complete information relating to the production and control of each batch.
- 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.
- 21 CFR 211.194(e). Stability testing records not included Laboratory records do not include complete records of all stability testing performed.
- 21 CFR 211.84(a). Components withheld from use pending release Each lot of components, drug product containers, and closures is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit.
- 21 CFR 211.188(b)(8). Labeling control records including specimens or copies Batch production and control records do not include complete labeling control records, including specimens or copies of all labeling used for each batch of drug product produced.
- 21 CFR 211.166(a)(4). Testing in same container - closure system The written stability program does not assure testing of the drug product in the same container-closure system as that in which the drug product is marketed.
- 21 CFR 211.166(b). Tentative expiration date Where data from accelerated studies was used to project a tentative expiration date beyond a date supported by actual shelf life studies, there were no stability studies conducted until the tentative expiration date was verified or the appropriate expiration date determined.
- 21 CFR 211.110(a). Written in-process control procedures Written procedures are not established and followed that describe the in-process controls, tests, and examinations to be conducted on appropriate samples of in-process materials of each batch.
- 21 CFR 211.22(a). Lack of quality control unit There is no quality control unit.
- 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 211.100(a). Approval and review of procedures Written procedures are not reviewed and approved by the quality control unit.
- 21 CFR 211.198(a). Complaints reviewed by Quality Control Unit Written procedures describing the handling of complaints do not include provisions for review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications, a determination as to the need for an investigation of any unexplained discrepancy, and explaining the reasons for the failure of the batch or any of its components to meet specifications.
- 21 CFR 211.166(a). Written program not followed The written stability testing program is not followed.
| Voluntary Action Indicated (VAI) |
| Aug 12, 2010 | Drugs · Drug Quality Assurance | 5 cited references- 21 CFR 211.137(a). Expiration date lacking Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
- 21 CFR 211.100(a). Approval and review of procedures Written procedures are not reviewed and approved by the quality control unit.
- 21 CFR 211.166(a). Results not used for expiration dates, storage cond. Results of stability testing are not used in determining expiration dates.
- 21 CFR 211.198(a). Complaints reviewed by Quality Control Unit Written procedures describing the handling of complaints do not include provisions for review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications, a determination as to the need for an investigation of any unexplained discrepancy, and explaining the reasons for the failure of the batch or any of its components to meet specifications.
- 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.
| Voluntary Action Indicated (VAI) |
