FDA establishment 2013342, Covina, California, United States. Part of GVS TM, Inc.'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
21 CFR 211.115(b). Reprocessing/quality control unit Reprocessing was performed without the review and approval of the quality control unit.
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 211.165(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.
21 CFR 211.194(a)(6). Test results, comparison with standards not included Laboratory records do not include a statement of the results of tests and how the results compare with established standards of identity, strength, quality, and purity for the drug product tested.
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.
21 CFR 211.80(a). Procedures To Be in Writing Written procedures are lacking which describe in sufficient detail the testing of components.
21 CFR 211.22(a). Approve or reject components, products The quality control unit lacks the responsibility and authority to approve and reject all components, drug product containers, closures, in process materials, packaging material, labeling and drug products.
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 211.103. Actual vs. theoretical yields not determined Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of of the drug product.
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, processing, packing and holding.
21 CFR 211.110(a). Written in-process control procedures Written procedures are not established that describe the in-process controls, tests and examinations to be conducted on appropriate samples of in-process materials of each batch.
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 211.165(b). Microbiological testing Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
21 CFR 211.42(c)(10)(iv). Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
21 CFR 211.194(a). Complete test data included in records Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
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.
No Action Indicated (NAI)
Aug 19, 2014
Devices · Compliance: DevicesDrugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Nov 8, 2012
Drugs · Drug Quality Assurance
5 cited references
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 211.84(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.
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 211.67(b). Written procedures fail to include Written procedures for cleaning and maintenance fail to include parameters relevant to the operation.
21 CFR 211.194(a)(4). Data secured in course of each test Laboratory records do not include a complete record of all data secured in the course of each test, including all graphs, charts, and spectra from laboratory instrumentation, properly identified to show the drug product tested.
Voluntary Action Indicated (VAI)
Mar 18, 2011
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Jun 25, 2010
Drugs · Drug Quality AssuranceBiologics · Blood and Blood Products; Devices · Compliance: Devices
3 cited references
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 identity, strength, quality, and purity of drug products.
21 CFR 211.42(c). Defined areas of adequate size for operations The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.
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.
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard and warning letters
Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
