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FDA establishment 3012553246, Conyers, Georgia, United States. Part of ABC Compounding Company's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
Inspections: 6
Official action indicated: 1
Last inspection ended: Apr 21, 2023
Warning letters: 2
Recalls since 2016: 1
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 211.160(b)(3). Drug products - samples representative, identified properly Samples taken of drug products for determination of conformance to written specifications are not representative.
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 211.84(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 211.115(a). Reprocessing procedures lack steps to be taken Reprocessing procedures lack the steps to be taken to insure that reprocessed batches will conform with all established standards, specifications, and characteristics.
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.
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components conform to appropriate standards of identity, strength, quality and purity.
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 211.67(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 211.137(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 211.166(a)(1). Sample size - test intervals The written stability program for drug products does not include test intervals based on statistical criteria for each attribute examined to assure valid estimates of stability.
21 CFR 211.165(f). Failing drug products not rejected Drug products failing to meet established specifications and quality control criteria are not rejected.
21 CFR 211.182. Written records kept in individual logs Written records of major equipment cleaning, maintenance and use are not included in individual equipment logs.
Official Action Indicated (OAI)
Apr 19, 2018
Drugs · Drug Quality Assurance
4 cited references
21 CFR 211.125(a). Strict control not exercised over labeling issued Strict control is not exercised over labeling issued for use in drug product labeling operations.
21 CFR 211.196. Distribution Record Requirements Distribution records do not contain the lot or control number of drug product.
21 CFR 211.186(a). Master production and control records, procedure The preparation of your master production and control records was not described in a written procedure.
21 CFR 211.170(b). Drug product reserve containers Drug product reserve samples are not stored in the same immediate container-closure system as the marketed product.
Voluntary Action Indicated (VAI)
Dec 21, 2015
Drugs · Drug Quality Assurance
2 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 211.100(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.
Voluntary Action Indicated (VAI)
Dec 16, 2015
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Oct 3, 2012
Drugs · Drug Quality Assurance
3 cited references
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 211.82(b). Quarantine Storage of Components Incoming components, drug product containers, and closures are not stored under quarantine until they have been tested or examined, as appropriate, and released.
21 CFR 211.80(a). Procedures To Be in Writing Written procedures are lacking which describe in sufficient detail the receipt, identification, storage, handling, and sampling of components, drug product containers, and closures.
Voluntary Action Indicated (VAI)
Jan 7, 2010
Drugs · Drug Quality Assurance
2 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 211.198(b)(2). Complaint Investigation/Follow-Up Findings Complaint records are deficient in that they do not include the findings of the follow-up.
Voluntary Action Indicated (VAI)
Warning Letters
Letters naming this establishment; each opens the letter
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. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. 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, warning letters and enforcement reports
Conyers, Georgia, United States. Part of