FDA establishment 2010939, Los Angeles, California, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
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 211.188(b). Batch production and Batch Control Record Requirements The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing and processing.
Voluntary Action Indicated (VAI)
Nov 29, 2022
Drugs · Drug Quality Assurance
5 cited references
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 documented on the laboratory records.
21 CFR 211.186(b)(9). Manufacturing Instructions and Specifications The master production and control records are deficient in that they do not include complete manufacturing, control, instructions and sampling.
21 CFR 211.198(a). Complaint Handling Procedure Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
21 CFR 211.192. Written record of investigation incomplete Written records of investigations into the failure of a batch or any of its components to meet specifications do not include the conclusions and follow-up.
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.
Voluntary Action Indicated (VAI)
Oct 27, 2016
Drugs · Drug Quality Assurance
5 cited references
21 CFR 211.110(a). Control procedures fail to include the following Control procedures fail to include adequacy of mixing to assure uniformity and homogeneity.
21 CFR 211.110(c). In-process materials characteristics testing In-process materials are not tested for identity and strength and approved or rejected by the quality control unit after storage for long periods.
21 CFR 211.192. Extent of discrepancy, failure investigations Investigations of an unexplained discrepancy 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 211.198(a). Complaint Handling Procedure Procedures describing the handling of written and oral complaints related to drug products are deficiently 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.
Voluntary Action Indicated (VAI)
Sep 10, 2014
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Dec 14, 2011
Drugs · Drug Quality AssuranceDrugs · Bioresearch Monitoring
7 cited references
21 CFR 211.80(b). Handling and Storage to Prevent Contamination There was a failure to handle and store components at all times in a manner to prevent contamination.
21 CFR 211.165(e). Test methods The accuracy, sensitivity, specificity, and reproducibility of test methods have not been established and documented.
21 CFR 211.111. 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 211.22(c). Approve or reject procedures or specs The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the quality of drug products.
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 211.165(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 211.84(d)(6). Microbiological Contamination Exam Each lot of a component that is liable to microbiological contamination that is objectionable in view of its intended use is not subjected to microbiological tests before use.
Voluntary Action Indicated (VAI)
Oct 28, 2010
Drugs · Bioresearch MonitoringDrugs · Drug Quality Assurance
None posted
Official Action Indicated (OAI)
Feb 3, 2010
Drugs · Drug Quality Assurance
2 cited references
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 211.192. Extent of discrepancy, failure investigations Investigations of an unexplained discrepancy did not extend to other drug products that may have been associated with the specific failure or discrepancy.
Voluntary Action Indicated (VAI)
Jun 22, 2009
Drugs · Postmarket Surv. and EpidemiologyDrugs · Drug Quality Assurance
4 cited references
21 CFR 314.81(b)(2). Timely submission An annual report was not submitted each year and within 60 days of the anniversary date of U.S. approval of the application to the FDA division responsible for reviewing the application.
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 314.80(b). Failure to review ADE information Adverse drug experience information obtained or otherwise received from any source was not promptly reviewed, including information from commercial marketing experience, post marketing clinical investigations, post marketing epidemiological/surveillance activities, reports in the scientific literature, and unpublished scientific papers.
21 CFR 314.80(b). Failure to develop written procedures Written procedures have not been developed for the surveillance, receipt, evaluation, and reporting to FDA of post marketing adverse drug experiences.
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