| Jun 30, 2026 | Devices · Compliance: DevicesDrugs · Drug Quality Assurance | 9 cited references- ISO 13485:2016 Clause 7.1. Required elements not determined in planning product realization In product realization planning your firm did not adequately determine, as appropriate, quality objectives and requirements for the product and required activities specific to the product together with criteria for product acceptance.
- ISO 13485:2016 Clause 8.2.1. Information gathered in feedback process not used as input into risk management Information gathered in the feedback process does not adequately serve as potential input into risk management for monitoring and maintaining product requirements as well as the product realization or improvement processes.
- 21 CFR 211.68(a). Calibration/Inspection/Checking not done Routine checking of automatic equipment is not performed according to a written program designed to assure proper performance.
- 21 CFR 314.81(b)(1)(ii). Contamination, chemical or physical change, deterioration An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning bacteriological contamination and significant chemical, physical, or other change or deterioration in a distributed drug product.
- 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 written and followed.
- 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 in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
- 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 211.192. 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 211.198(b). Written complaint record to be maintained at facility A written record of each complaint is not maintained in a file designated for drug product complaints at the facility where the drug product was manufactured, processed or packed.
| Voluntary Action Indicated (VAI) |
| Jun 5, 2024 | Devices · Compliance: DevicesDrugs · Drug Quality Assurance | 9 cited references- 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 in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
- 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 820.50. Purchasing controls, Lack of or inadequate procedures Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.
- 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 820.30(g). Design validation - Risk analysis Results of the design risk analysis were not adequately documented.
- 21 CFR 211.165(d). Acceptance criteria for sampling & testing Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet each appropriate specification and appropriate statistical quality control criteria as a condition for their approval and release.
- 21 CFR 820.30(d). Design output - Lack of or inadequate procedures Procedures for design output have not been adequately established.
- 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 written and followed.
- 21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
| Voluntary Action Indicated (VAI) |
| Dec 21, 2019 | Devices · Compliance: DevicesDrugs · Drug Quality Assurance; Devices · Postmarket Assurance: Devices | 11 cited references- 21 CFR 211.166(a)(3). Valid stability test methods The written stability program for drug products does not include meaningful test methods.
- 21 CFR 820.50. Purchasing controls, Lack of or inadequate procedures Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been established.
- 21 CFR 820.75(a). Lack of or inadequate process validation A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.
- 21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
- 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(g). Design validation- Lack of or inadequate procedures Procedures for design validation have not been adequately established.
- 21 CFR 820.198(a). Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been established.
- 21 CFR 820.80(d). Lack of or inadequate final acceptance procedures Procedures for finished device acceptance have not been adequately established.
- 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 820.30(h). Design transfer - Lack of or inadequate procedures Procedures for design transfer have not been adequately established.
- 21 CFR 820.80(b). Lack of or inadequate receiving acceptance procedures Procedures for acceptance of incoming product have not been adequately established.
| Official Action Indicated (OAI) |
| Mar 24, 2017 | Drugs · Drug Quality AssuranceDevices · Compliance: Devices | None posted | Official Action Indicated (OAI) |
| Mar 23, 2015 | Drugs · Drug Quality Assurance | None posted | Voluntary Action Indicated (VAI) |
| Nov 25, 2014 | Devices · Compliance: DevicesDrugs · Drug Quality Assurance | 13 cited references- 21 CFR 211.100(b). SOPs not followed / documented Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance.
- 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.
- 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 211.166(a). Written program not followed The written stability testing program is not followed.
- 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 and written procedures required by current good manufacturing practice regulations.
- 21 CFR 211.22(a). Authority lacking to review records, investigate errors The quality control unit lacks authority to review production records to assure that no errors have occurred and fully investigate errors that have occurred.
- 21 CFR 314.81(b)(1)(ii). Contamination, chemical or physical change, deterioration An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product.
- 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 drug products that may have been associated with the specific failure or discrepancy.
- 21 CFR 211.192. Written record of investigation incomplete Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
- 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 211.198(b)(2). Complaint Investigation/Follow-Up Findings Complaint records are deficient in that they do not include the findings of the investigation and follow-up.
- 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 211.180(e)(2). Items to cover on annual reviews Written procedures are not followed for evaluations done at least annually and including provisions for a review of complaints and investigations conducted for each drug product.
| Official Action Indicated (OAI) |
| Feb 21, 2014 | Drugs · Drug Quality AssuranceDevices · Compliance: Devices | None posted | Official Action Indicated (OAI) |
| Feb 21, 2014 | Devices · Compliance: DevicesDrugs · Drug Quality Assurance | None posted | Official Action Indicated (OAI) |
| Oct 9, 2013 | Drugs · Drug Quality Assurance | None posted | Official Action Indicated (OAI) |
| Oct 9, 2013 | Drugs · Drug Quality Assurance | None posted | Official Action Indicated (OAI) |
| Apr 29, 2013 | Drugs · Drug Quality Assurance | None posted | Official Action Indicated (OAI) |
| Mar 4, 2013 | Drugs · Drug Quality AssuranceDevices · Compliance: Devices | None posted | Official Action Indicated (OAI) |
| Feb 13, 2012 | Drugs · Drug Quality Assurance | None posted | Voluntary Action Indicated (VAI) |
| Feb 13, 2012 | Drugs · Drug Quality Assurance | 4 cited references- 21 CFR 211.100(b). SOPs not followed / documented Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance.
- 21 CFR 211.160(a). Following/documenting laboratory controls Established laboratory control mechanisms are not followed.
- 21 CFR 211.80(a). Written Procedures Not Followed Written procedures are not followed for the handling of components.
- 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 written and followed.
| Voluntary Action Indicated (VAI) |
| May 12, 2011 | Drugs · Drug Quality Assurance | None posted | No Action Indicated (NAI) |
| Aug 18, 2010 | Drugs · Drug Quality Assurance | None posted | Voluntary Action Indicated (VAI) |
| Aug 18, 2010 | Drugs · Drug Quality Assurance | 3 cited references- 21 CFR 211.100(b). SOPs not followed / documented Written production and process control procedures are not followed in the execution of production and process control functions.
- 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.
- 21 CFR 211.58. Buildings not maintained in good state of repair Buildings used in the manufacturing and processing of a drug product are not maintained in a good state of repair.
| Voluntary Action Indicated (VAI) |
| Jul 31, 2009 | Drugs · Drug Quality AssuranceDrugs · Bioresearch Monitoring | None posted | Voluntary Action Indicated (VAI) |
| Jul 31, 2009 | Drugs · Drug Quality AssuranceDrugs · Bioresearch Monitoring | 3 cited references- 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.
- 21 CFR 211.100(b). SOPs not followed / documented Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance.
- 21 CFR 211.182. Personnel dating/signing equipment log The persons double-checking the cleaning and maintenance are not dating the equipment cleaning and use log.
| Voluntary Action Indicated (VAI) |
