| Apr 2, 2026 | Drugs · Drug Quality Assurance | 10 cited references- FDCA 582(b)(4). Systems in place to comply with verification requirements Your firm failed to have systems in place to enable compliance with the verification requirements of the DSCSA.
- FDCA 582(g)(1). Establishing Enhanced Systems Your firm failed to establish secure, interoperable, electronic systems and processes necessary to process requests for verification at the package level, respond with the relevant transaction information (at the package level) and transaction statement for a product upon request by FDA or other appropriate Federal or State official in the event of a recall or for the purposes of investigating a suspect product or an illegitimate product and associate a saleable return product with its applicable transaction information and transaction statement to allow a trading partner to accept the returned product.
- 21 CFR 211.100(a). Absence of Written Procedures Your firm failed to establish 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 211.68(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 211.192. 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 211.166(b). Adequate number of batches on stability An adequate number of batches of each drug product are not tested to determine an appropriate expiration date.
- 21 CFR 211.84(b). Representative Samples Criteria The number of containers to be sampled is not based upon appropriate criteria.
- 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 established.
- 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 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
| Official Action Indicated (OAI) |
| Sep 20, 2024 | Drugs · Bioresearch Monitoring | 2 cited references- 21 CFR 314.80(c)(1)(i). Late submission of 15-day report Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information.
- 21 CFR 314.80(b). Failure to develop written procedures Written procedures have not been developed for the of post marketing adverse drug experiences.
| Voluntary Action Indicated (VAI) |
| Sep 13, 2024 | Drugs · Drug Quality Assurance | None posted | Voluntary Action Indicated (VAI) |
| Apr 21, 2021 | Drugs · Drug Quality Assurance | 2 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 211.192. Extent of discrepancy, failure investigations Investigations of a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
| Voluntary Action Indicated (VAI) |
| Apr 4, 2016 | Drugs · Bioresearch MonitoringDrugs · Drug Quality Assurance | None posted | No Action Indicated (NAI) |
| Feb 19, 2014 | Drugs · Drug Quality Assurance | None posted | Voluntary Action Indicated (VAI) |
| Jan 30, 2013 | Drugs · Drug Quality Assurance | None posted | Voluntary Action Indicated (VAI) |
| Nov 5, 2010 | Drugs · Drug Quality Assurance | 13 cited references- 21 CFR 211.22(a). Lack of quality control unit There is no quality control unit.
- 21 CFR 211.67(b)(3). Cleaning SOPs/instructions Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.
- 21 CFR 211.115(a). Reprocessing procedures not written or followed Procedures prescribing a system for reprocessing batches to insure that the reprocessed batches will conform with all established standards, specifications, and characteristics are not written.
- 21 CFR 211.111. Deviations of production time limits Deviations from production time limits are not justified and are not documented.
- 21 CFR 211.165(e). Test methods The accuracy, sensitivity, specificity, and reproducibility of test methods have not been established and documented.
- 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 211.100(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 211.25(a). Training , Education , Experience overall Employees engaged in the manufacture, processing, packing, and holding of a drug product lack the training and experience required to perform their assigned functions.
- 21 CFR 211.103. Actual vs. theoretical yields not determined Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of manufacturing, processing, packaging, and holding of the 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 batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
- 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 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(b). Adequate number of batches on stability An adequate number of batches of each drug product are not tested nor are records of such data maintained to determine an appropriate expiration date.
| Voluntary Action Indicated (VAI) |
| Dec 1, 2009 | Drugs · Drug Quality AssuranceDrugs · Bioresearch Monitoring | 11 cited references- 21 CFR 211.192. Extent of discrepancy, failure investigations Investigations of a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product.
- 21 CFR 211.165(e). Test methods The accuracy, sensitivity, specificity, and reproducibility of test methods have not been established and documented.
- 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 211.160(a). Lab controls established, including changes The establishment of test procedures including any changes thereto, are not 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 211.100(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 211.165(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 appropriate statistical quality control criteria as a condition for their approval and release.
- 21 CFR 314.81(b)(2)(iv)(a). Reports re: chemical, physical, or other properties An annual report did not include reports of experiences involving chemical or physical properties which, as new information, might affect FDA's previous conclusions about the safety or effectiveness of the drug.
- 21 CFR 211.137(a). Expiration date lacking Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
- 21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
- 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.
| Official Action Indicated (OAI) |
| Nov 14, 2008 | Drugs · Drug Quality Assurance | 14 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 211.137(a). Expiration date lacking Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
- 21 CFR 211.165(e). Test methods The accuracy, sensitivity, specificity, and reproducibility of test methods have not been established.
- 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 211.56(b). Written sanitation procedures lacking There is a lack of written procedures assigning responsibility for sanitation.
- 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 211.194(a)(5). Calculations performed are in the records Laboratory records do not include a record of all calculations performed in connection with the test.
- 21 CFR 211.194(a)(8). Second person sign off Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established standards.
- 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 211.160(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 211.42(b). Product flow through building is inadequate The flow of components, drug product containers, closures, labeling, in-process materials, and drug products though the building is not designed to prevent contamination.
- 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.
- 21 CFR 211.67(b)(3). Cleaning SOPs/instructions Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.
- 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 final specifications prior to release.
| Official Action Indicated (OAI) |
Kansas City, Missouri, United States. Part of