| Apr 3, 2026 | 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 211.142. Written warehousing procedures established/followed Procedures describing the warehousing of drug products are not established and followed.
- 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.
| Official Action Indicated (OAI) |
| Mar 24, 2023 | Drugs · Drug Quality Assurance | 8 cited references- 21 CFR 211.180(e)(1). Review of representative number of batches Written procedures are not followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
- 21 CFR 211.142. Written warehousing procedures established/followed Procedures describing the warehousing of drug products are not established and followed.
- 21 CFR 211.25(a). GMP Training Frequency GMP training is not conducted on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
- 21 CFR 211.198(a). Complaint Handling Procedure Procedures describing the handling of written and oral complaints related to drug products are not written or 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 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
- 21 CFR 211.182. Personnel dating/signing equipment log The persons performing and double-checking the cleaning and maintenance are not signing or initialing the equipment cleaning and use log.
- 21 CFR 211.160(b)(4). Calibration - at intervals, written program, remedial action The calibration of instruments and apparatus is not done at suitable intervals.
| Voluntary Action Indicated (VAI) |
| Feb 3, 2020 | Drugs · Drug Quality Assurance | 4 cited references- 21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the safety, identity, strength, quality or purity of the drug product.
- 21 CFR 211.194(c). Testing and standardization of standards et. al. Laboratory records do not include complete records of any testing and standardization of laboratory reference standards.
- 21 CFR 211.25(a). GMP Training Frequency GMP training is not conducted on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
- 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.
| Voluntary Action Indicated (VAI) |
| May 25, 2018 | Drugs · Drug Quality Assurance | 8 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 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
- 21 CFR 211.100(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 and packing of a drug product lack the training required to perform their assigned functions.
- 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 212.60(g)(3). Complete record of all laboratory test data Laboratory test records did not contain a complete record of all data obtained in the course of each test, including all graphs, charts, and spectra from laboratory instrumentation, properly identified to show the specific component, in-process material, or drug product for each lot tested.
- 21 CFR 211.22(a). Lack of quality control unit There is no quality control unit.
- 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 components and drug product containers conform to appropriate standards of identity, strength, quality and purity.
| Voluntary Action Indicated (VAI) |
| Feb 7, 2018 | Drugs · Drug Quality Assurance | None posted | No Action Indicated (NAI) |
| Jan 8, 2016 | Drugs · Drug Quality Assurance | None posted | Voluntary Action Indicated (VAI) |
| Oct 17, 2014 | Drugs · Drug Quality Assurance | 2 cited references- 21 CFR 211.28(c). Unauthorized Personnel in Limited Access Areas Unauthorized personnel have access to enter areas of the buildings and facilities designated as limited access areas.
- 21 CFR 211.68(a). Written calibration / inspection records not kept Records of the calibration checks and inspections of automatic, mechanical or electronic equipment, including computers or related systems are not maintained.
| Voluntary Action Indicated (VAI) |
| Nov 30, 2012 | Drugs · Drug Quality Assurance | 4 cited references- 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 211.165(e). Test methods The accuracy, sensitivity, and specificity of test methods have not been established and documented.
- 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 211.63. Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design, of adequate size, and suitably located to facilitate operations for its intended use and cleaning and maintenance.
| Voluntary Action Indicated (VAI) |
| Nov 9, 2012 | Drugs · Drug Quality Assurance | None posted | No Action Indicated (NAI) |
| Oct 26, 2011 | Drugs · Drug Quality Assurance | 7 cited references- 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 211.196. Distribution Record Requirements Distribution records do not contain the name and strength of the drug product.
- 21 CFR 211.68(a). Calibration/Inspection/Checking not done Routine checking of electronic equipment is not performed according to a written program designed to assure proper performance.
- 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 conform to appropriate standards of identity, strength, quality and purity.
- 21 CFR 211.84(d)(2). Establish reliability of supplier's C of A Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
- 21 CFR 211.166(a). Results not used for expiration dates, storage cond. Results of stability testing are not used in determining expiration dates.
- 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.
| Voluntary Action Indicated (VAI) |
| Aug 30, 2010 | Drugs · Drug Quality Assurance | 2 cited references- 21 CFR 211.180(e)(1). Review of representative number of batches Written procedures are not established and followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
- 21 CFR 211.80(a). Procedures To Be in Writing Written procedures are lacking which describe in sufficient detail the receipt of components, drug product containers, and closures.
| Voluntary Action Indicated (VAI) |
| May 14, 2010 | Drugs · Drug Quality Assurance | 3 cited references- 21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review 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 211.67(c). Cleaning/maintenance records not kept Records are not kept for the maintenance of equipment.
- 21 CFR 211.25(a). Training , Education , Experience overall Employees engaged in the processing and holding of a drug product lack the training required to perform their assigned functions.
| Voluntary Action Indicated (VAI) |
| Jun 25, 2009 | Drugs · Drug Quality Assurance | 4 cited references- 21 CFR 211.180(e)(1). Review of representative number of batches Written procedures are not followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
- 21 CFR 211.100(a). Approval and review of procedures Written procedures are not drafted, reviewed and approved by the appropriate organizational units and reviewed and approved by the quality control unit.
- 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. 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.
| Voluntary Action Indicated (VAI) |
Chatsworth, California, United States. Part of