| Sep 3, 2026 | Drugs · Drug Quality Assurance | 1 cited reference- 21 CFR 211.67(b)(2). Cleaning SOPs/schedules Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including, where appropriate, sanitizing schedules.
| Voluntary Action Indicated (VAI) |
| Sep 20, 2023 | Drugs · Drug Quality Assurance | 5 cited references- 21 CFR 211.67(b). Written procedures not established/followed Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
- 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.
- 21 CFR 211.142(b). Storage under appropriate conditions Drug products are not stored under appropriate conditions of temperature and humidity so that their identity, strength, quality, and purity are not affected.
- 21 CFR 211.22(a). Approve or reject components, products The quality control unit lacks the responsibility and authority to approve and reject all drug products.
- 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.
| Voluntary Action Indicated (VAI) |
| Nov 19, 2021 | Drugs · Drug Quality Assurance | 3 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 211.22(a). Contract drug products--lack of responsibility The quality control unit lacks responsibility for approving or rejecting drug products packed under contract by another company.
- 21 CFR 211.67(b). Written procedures not established/followed Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
| Official Action Indicated (OAI) |
| Jun 29, 2018 | Drugs · Drug Quality Assurance | 5 cited references- 21 CFR 211.67(b). Written procedures not established/followed Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
- 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 211.166(a). Lack of written stability program There is no written testing program designed to assess the stability characteristics of drug products.
- 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 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
| Voluntary Action Indicated (VAI) |
| Dec 1, 2016 | Drugs · Drug Quality Assurance | 1 cited reference- 21 CFR 211.67(b). Written procedures not established/followed Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
| Voluntary Action Indicated (VAI) |
| Nov 12, 2014 | Drugs · Drug Quality Assurance | None posted | Voluntary Action Indicated (VAI) |
| Oct 7, 2013 | Drugs · Drug Quality Assurance | None posted | Voluntary Action Indicated (VAI) |
| Nov 15, 2011 | Drugs · Drug Quality Assurance | 7 cited references- 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 211.100(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 211.192. 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(b). Microbiological testing Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
- 21 CFR 211.160(b)(3). Drug products - samples representative, identified properly Samples taken of drug products for determination of conformance to written specifications are not representative.
- 21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
- 21 CFR 211.67(b). Written procedures not established/followed Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
| Voluntary Action Indicated (VAI) |
| Aug 3, 2010 | Drugs · Drug Quality Assurance | 4 cited references- 21 CFR 211.67(c). Cleaning/maintenance records not kept Records are not kept for the maintenance, cleaning, and inspection of equipment.
- 21 CFR 211.80(d). Status of Each Lot Identified Each lot of components, drug product containers, and closures was not appropriately identified as to its status in terms of being quarantined, approved or rejected.
- 21 CFR 211.130. Procedures are written, and followed Procedures designed to assure that correct labels, labeling, and packaging materials are used for drug products are not written and followed.
- 21 CFR 211.130(e). Packaging line inspection after use Inspection of the packaging and labeling facilities is not done after use to assure that materials not suitable for subsequent operations have been removed.
| Voluntary Action Indicated (VAI) |
| Feb 11, 2009 | Drugs · Drug Quality Assurance | 4 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 211.130. Procedures are written, and followed Procedures designed to assure that correct labeling and packaging materials are used for drug products are not 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 211.122(b). Labeling and packaging improperly approved/released Labeling and packaging materials not meeting the appropriate written specifications were approved and released for use.
| Voluntary Action Indicated (VAI) |
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