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21 CFR 211.180(e)(2). Items to cover on annual reviews Written procedures are not established for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products and investigations conducted for each drug product.
21 CFR 211.170(a). Active ingredient retained sample kept A sample which is representative of each lot in each shipment of each active ingredient is not appropriately identified and retained.
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 211.198(a). Procedures to be written and followed Procedures describing the handling of all written and oral complaints regarding a drug product are not established and written.
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 and identity and strength of each active ingredient prior to release.
21 CFR 211.166(a). Written program not followed The written stability testing program is not followed.
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, sampling plans and test procedures designed to assure that components, in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.196. Distribution Record Requirements Distribution records do not contain the lot or control number of drug product.
21 CFR 211.186(b)(9). Complete instructions, procedures, specifications et. al. Master production and control records lack complete manufacturing and control instructions, sampling and testing procedures and specifications.
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 211.84(d)(2). Reports of Analysis (Components) Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component and establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
21 CFR 211.25(a). Training--operations, GMPs, written procedures Employees are not given training in current good manufacturing practices and written procedures required by current good manufacturing practice regulations.
Official Action Indicated (OAI)
Jul 18, 2022
Drugs · Drug Quality Assurance
9 cited references
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 211.165(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 and identity and strength of each active ingredient prior to release.
21 CFR 211.196. Distribution Record Requirements Distribution records do not contain the date and quantity shipped.
21 CFR 211.84(d)(2). Reports of Analysis (Components) Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component and establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
21 CFR 211.166(a). Written program not followed The written stability testing program is not followed.
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 211.22(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 211.186(b)(9). Complete instructions, procedures, specifications et. al. Master production and control records lack complete manufacturing and control instructions, sampling and testing procedures and specifications.
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.
Official Action Indicated (OAI)
Dec 8, 2016
Drugs · Drug Quality Assurance
14 cited references
21 CFR 211.101(d). Verification of component addition Each component is not added to the batch by one person and verified by a second person..
21 CFR 211.192. Quality control unit review of records Drug product production and control records, are not reviewed by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
21 CFR 211.150(a). Distribution of oldest approved drugs The oldest approved stock of drug products are not distributed first and there is no justification for this practice.
21 CFR 211.186(b)(8). Description of containers, labels, et. al. Master production and control records lack a specimen or copy of each label and all other labeling and the signatures and dates entered by the person or persons responsible for the approval of labeling.
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 211.166(a). Written program not followed The written stability testing program is not followed.
21 CFR 211.84(d)(2). Reports of Analysis (Components) Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component and establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
21 CFR 211.198(a). Reporting of adverse drug experience to FDA Written procedures describing the handling of all written and oral complaints do not include provisions for review to determine whether the complaint represents a serious and unexpected adverse drug experience which is required to be reported to the Food and Drug Administration.
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, current good manufacturing practices and written procedures required by current good manufacturing practice regulations.
21 CFR 211.130(e). Packaging line inspection before use Inspection of the packaging and labeling facilities immediately before use is not done to assure that all drug products have been removed from previous operations.
21 CFR 211.122(a). Written procedures describing in detail There is a lack of written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, examination and testing of labeling and packaging materials.
21 CFR 211.150(b). Recall facilitation A system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary, has not been established.
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(b). Representative Samples Representative samples are not taken of each shipment of each lot of components for testing or examination.
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
Hapeville, Georgia, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.