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FDA establishment 1000110937, College Park, Georgia, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 6
Official action indicated: 0
Last inspection ended: Feb 21, 2025
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 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 211.63. 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 211.115(a). Reprocessing procedures not written or followed Procedures prescribing a system for reprocessing batches to insure that the reprocessed batches will conform with all established standards, specifications, and characteristics are not written.
21 CFR 211.67(b). Written procedures not established/followed Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
21 CFR 211.142(b). Storage under appropriate conditions Drug products are not stored under appropriate conditions of temperature and humidity so that their identity, strength, quality, and purity are not affected.
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)
Feb 14, 2019
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Feb 22, 2017
Drugs · Drug Quality Assurance
11 cited references
21 CFR 211.192. Extent of discrepancy, failure investigations Investigations of 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.
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 211.182. Written records kept in individual logs Written records of major equipment cleaning and use are not included in individual equipment logs.
21 CFR 211.186(a). Written procedures followed Procedures for the preparation of master production and control records are not followed.
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 211.188. 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 211.192. 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 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not fully followed.
21 CFR 211.84(d)(1). Identity Testing of Each Component The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.
21 CFR 211.142(b). Storage under appropriate conditions Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected.
21 CFR 211.25(b). Supervisor Training/Education/Experience Individuals responsible for supervising the manufacture, processing, packing and holding of a drug product lack the training to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality and purity that it purports or is represented to possess.
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
College Park, Georgia, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.