| Oct 20, 2025 | Drugs · Drug Quality Assurance | 4 cited references- 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.
- 21 CFR 211.113(b). Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
- 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 211.63. 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.
| Official Action Indicated (OAI) |
| Apr 14, 2023 | Drugs · Drug Quality Assurance | 1 cited reference- 21 CFR 211.113(b). Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
| Voluntary Action Indicated (VAI) |
| Oct 22, 2021 | Biologics · Blood and Blood ProductsBiologics · Vaccines and Allergenic Products | None posted | Voluntary Action Indicated (VAI) |
| Apr 15, 2019 | Drugs · Drug Quality Assurance | 1 cited reference- 21 CFR 211.188(b). Batch production and Batch Control Record Requirements The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing.
| Voluntary Action Indicated (VAI) |
| Aug 9, 2018 | Biologics · Vaccines and Allergenic ProductsBiologics · Blood and Blood Products | None posted | Voluntary Action Indicated (VAI) |
| Mar 13, 2017 | Drugs · Drug Quality Assurance | 1 cited reference- 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.
| Voluntary Action Indicated (VAI) |
| Sep 28, 2015 | Drugs · Drug Quality Assurance | None posted | No Action Indicated (NAI) |
| Sep 10, 2015 | Drugs · Drug Quality Assurance | None posted | Voluntary Action Indicated (VAI) |
| Feb 10, 2014 | Drugs · Drug Quality Assurance | None posted | Voluntary Action Indicated (VAI) |
| Dec 28, 2012 | Drugs · Drug Quality Assurance | None posted | Voluntary Action Indicated (VAI) |
| Mar 29, 2012 | Drugs · Drug Quality Assurance | 3 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 211.22(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. Written record of investigation incomplete Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
| Voluntary Action Indicated (VAI) |
| Aug 5, 2011 | Biologics · Blood and Blood Products | None posted | Voluntary Action Indicated (VAI) |
| Jun 8, 2011 | Drugs · Drug Quality Assurance | 3 cited references- 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 211.198(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 211.192. Written record of investigation incomplete Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
| Voluntary Action Indicated (VAI) |
| Aug 31, 2010 | Drugs · Drug Quality Assurance | 3 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.
- 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 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
| Voluntary Action Indicated (VAI) |
| Feb 18, 2010 | Drugs · Drug Quality Assurance | 4 cited references- 21 CFR 211.42(c)(10)(iv). Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
- 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.
- 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 211.67(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) |
| Sep 22, 2009 | Biologics · Blood and Blood Products | None posted | Voluntary Action Indicated (VAI) |
| Jul 17, 2009 | Drugs · Drug Quality Assurance | None posted | Voluntary Action Indicated (VAI) |
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