| Mar 26, 2026 | Drugs · Drug Quality Assurance | 10 cited references- 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 211.111. 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 211.160(b)(4). Instruments, apparatus, et. al. not meeting specs The use of instruments not meeting established specifications was observed.
- 21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
- 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 211.194(a)(2). Laboratory Test Method Verification Verification of the suitability of the testing methods is deficient in that they are not.
- 21 CFR 211.67(c). Cleaning/maintenance records not kept Records are not kept for the maintenance, cleaning, sanitizing and inspection of equipment.
- 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 211.84(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 211.160(a). Lab controls established, including changes The establishment of laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit.
| Official Action Indicated (OAI) |
| Oct 31, 2024 | Drugs · Drug Quality Assurance | 6 cited references- 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 211.192. 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 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 211.166(a). Lack of written stability program There is no written testing program designed to assess the stability characteristics of drug products.
- 21 CFR 211.68(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 211.84(d)(2). Testing Each Component for Conformity with Specs Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
| Official Action Indicated (OAI) |
| Nov 20, 2023 | Drugs · Drug Quality Assurance | 7 cited references- 21 CFR 211.180(e). Records reviewed annually Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures.
- 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 211.63. 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 211.166(a). Lack of written stability program There is no written testing program designed to assess the stability characteristics of drug products.
- 21 CFR 211.22(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 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 components, drug product containers, in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
| Official Action Indicated (OAI) |
| Apr 5, 2022 | Drugs · Drug Quality Assurance | 4 cited references- 21 CFR 211.100(a). Changes to Procedures Not Reviewed, Approved Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit and reviewed and approved by the quality control unit.
- 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 211.113(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 211.68(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 2, 2019 | Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices | 5 cited references- 21 CFR 820.184. DHR content The device history record does not demonstrate that the device was manufactured in accordance with the device master record.
- 21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
- 21 CFR 820.70(g). Equipment Installation, Placement, Specified Requirements The equipment used in the manufacturing process does not meet specified requirements.
- 21 CFR 820.70(c). Environmental control Lack of or inadequate procedures Procedures to control environmental conditions 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.
| No Action Indicated (NAI) |
| May 30, 2019 | Drugs · Drug Quality Assurance | 3 cited references- 21 CFR 211.160(a). Lab controls established, including changes The establishment of laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit.
- 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 211.113(a). Procedures for non-sterile drug products Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established.
| Voluntary Action Indicated (VAI) |
| Feb 5, 2016 | Drugs · Drug Quality Assurance | 4 cited references- 21 CFR 211.160(a). Lab controls established, including changes The establishment of sampling plans and laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit and reviewed and approved by the quality control unit .
- 21 CFR 211.166(a). Written program not followed The written stability testing program is 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 .
- 21 CFR 211.100(a). Changes to Procedures Not Reviewed, Approved Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit and reviewed and approved by the quality control unit .
| Voluntary Action Indicated (VAI) |
| Feb 25, 2015 | Drugs · Drug Quality Assurance | 10 cited references- 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 211.160(a). Lab controls established, including changes The establishment of specifications including any changes thereto, are not drafted by the appropriate organizational unit and reviewed and approved by the quality control unit.
- 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 211.25(a). Training--operations, GMPs, written procedures Employees are not given training in the particular operations they perform as part of their function.
- 21 CFR 211.100(a). Changes to Procedures Not Reviewed, Approved Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit and reviewed and approved by the quality control unit.
- 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 211.165(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.
- 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 211.165(f). Failing drug products not rejected Drug products failing to meet established standards, specifications, and quality control criteria are not rejected.
- 21 CFR 211.186(a). Written procedures followed Procedures for the preparation of master production and control records are not described in a written procedure.
| Voluntary Action Indicated (VAI) |
| Apr 11, 2012 | Drugs · Drug Quality Assurance | 3 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 211.166(a). Written program not followed The written stability testing program is not followed.
- 21 CFR 211.44. Adequate lighting not provided Adequate lighting is not provided in all areas.
| Voluntary Action Indicated (VAI) |
| Oct 20, 2010 | Drugs · Drug Quality Assurance | 2 cited references- 21 CFR 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which 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 211.67(b). Written procedures not established/followed Written procedures are not followed 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) |
| Dec 22, 2009 | Drugs · Drug Quality Assurance | None posted | Voluntary Action Indicated (VAI) |
| Apr 21, 2009 | Drugs · Drug Quality Assurance | None posted | No Action Indicated (NAI) |
