| Apr 2, 2026 | Drugs · Drug Quality Assurance | 9 cited references- 21 CFR 211.160(a). Following/documenting laboratory controls Established specifications, standards, sampling plans, test procedures and laboratory control mechanisms are not followed and documented at the time of performance.
- 21 CFR 211.100(b). Procedure Deviations Recorded and Justified Deviations from written production and process control procedures are not recorded.
- 21 CFR 211.165(d). Acceptance/Rejection Levels The statistical quality control criteria fail to include appropriate acceptance levels and rejection levels.
- 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 211.25(a). Training--operations, GMPs, written procedures Employees are not given training in the particular operations they perform as part of their function.
- 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 211.42(c). Defined areas of adequate size for operations The control systems necessary to prevent contamination or mix-ups are deficient.
- 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 211.113(b). Validation lacking for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process.
| Official Action Indicated (OAI) |
| Nov 25, 2025 | Biologics · Blood and Blood Products | 5 cited references- 21 CFR 211.25(a). Training , Education , Experience overall Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions.
- 21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
- 21 CFR 211.194(a)(1). Sample identification and other information Laboratory records do not include a description of the sample received for testing, the quantity of the sample and the date the sample was received for 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 211.68(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.
| Voluntary Action Indicated (VAI) |
| Aug 1, 2024 | Drugs · Drug Quality Assurance | None posted | Official Action Indicated (OAI) |
| Aug 18, 2023 | Devices · Compliance: Devices | 1 cited reference- 21 CFR 820.30(g). Design validation- Lack of or inadequate procedures Procedures for design validation have not been adequately established.
| Voluntary Action Indicated (VAI) |
| Jul 14, 2017 | Biologics · Blood and Blood Products | None posted | Voluntary Action Indicated (VAI) |
| Mar 8, 2017 | Drugs · Drug Quality Assurance | None posted | No Action Indicated (NAI) |
| Dec 15, 2016 | Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices | None posted | No Action Indicated (NAI) |
| Jul 7, 2015 | Biologics · Blood and Blood ProductsDrugs · Drug Quality Assurance | None posted | Voluntary Action Indicated (VAI) |
| Jun 19, 2015 | Devices · Compliance: DevicesDrugs · Drug Quality Assurance | None posted | Official Action Indicated (OAI) |
| Sep 17, 2013 | Biologics · Blood and Blood Products | None posted | Voluntary Action Indicated (VAI) |
| Jul 29, 2013 | Drugs · Drug Quality AssuranceDevices · Compliance: Devices; Devices · Postmarket Assurance: Devices | None posted | Official Action Indicated (OAI) |
| Jun 7, 2012 | Devices · Compliance: DevicesDrugs · Drug Quality Assurance; Devices · Postmarket Assurance: Devices | 9 cited references- 21 CFR 820.198(c). Investigation of device failures Complaints involving the possible failure of a device to meet any of its specifications were not evaluated where necessary.
- 21 CFR 820.30(i). Design changes - Lack of or Inadequate Procedures Procedures for design change have not been adequately established.
- 21 CFR 803.50(a)(2). Individual Report of Malfunction An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
- 21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
- 21 CFR 211.94(a). Reactive/Additive/Absorptive Containers/Closures Drug product containers or closures are additive so as to alter the safety, identity, strength, quality, and purity of the drug beyond the official or established requirements.
- 21 CFR 820.30(f). Design verification - output does not meet input requirement Design verification does not confirm that design output meets design input requirements.
- 21 CFR 820.30(f). Design verification - documentation The design verification results, including method(s), were not adequately documented in the design history file.
- 21 CFR 820.30(c). Design input - Lack of or inadequate procedures Procedures for design input have not been adequately established.
- 21 CFR 820.30(f). Design verification - Lack of or inadequate procedures Procedures for design verification have not been adequately established.
| Official Action Indicated (OAI) |
| Mar 18, 2011 | Biologics · Blood and Blood ProductsDevices · Compliance: Devices; Devices · Postmarket Assurance: Devices; Drugs · Drug Quality Assurance | 4 cited references- 21 CFR 803.50(a)(2). Individual Report of Malfunction An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
- 21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
- 21 CFR 820.198(c). Investigation of device failures Complaints involving the possible failure of a device to meet any of its specifications were not reviewed, evaluated, and investigated where necessary.
- 21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been implemented.
| Voluntary Action Indicated (VAI) |
| Sep 22, 2010 | Drugs · Bioresearch MonitoringDevices · Compliance: Devices; Drugs · Drug Quality Assurance | None posted | No Action Indicated (NAI) |
| Sep 2, 2010 | Drugs · Drug Quality Assurance | None posted | No Action Indicated (NAI) |
| Jun 8, 2010 | Drugs · Drug Quality Assurance | None posted | No Action Indicated (NAI) |
| Feb 15, 2010 | Drugs · Drug Quality Assurance | None posted | No Action Indicated (NAI) |
| Sep 9, 2009 | Drugs · Drug Quality AssuranceBiologics · Blood and Blood Products | None posted | Voluntary Action Indicated (VAI) |
| Feb 13, 2009 | Drugs · Drug Quality Assurance | None posted | No Action Indicated (NAI) |
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