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FDA establishment 3000220439, Marietta, Georgia, United States. Part of Cosco International's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 3
Official action indicated: 1
Last inspection ended: Oct 25, 2024
Warning letters: 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 211.196. Distribution Record Requirements Distribution records do not contain the name and strength of the drug product, name and address of consignee, date and quantity shipped and lot or control number of drug product.
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate 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 211.198(a). Complaint Handling Procedure Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
21 CFR 211.110(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)(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.
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 211.84(e). Rejecting When Specifications Not Met Failure to reject any lot of components that did not meet the appropriate written specifications for identity, strength, quality, and purity.
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 211.68(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.
Official Action Indicated (OAI)
Dec 14, 2018
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Nov 29, 2016
Drugs · Drug Quality Assurance
12 cited references
21 CFR 211.166(b). Adequate number of batches on stability An adequate number of batches of each drug product are not tested nor are records of such data maintained to determine an appropriate expiration date.
21 CFR 211.186(a). Signature and checking of records -- 2 persons The master production and control records for each batch size of drug product are not prepared, dated, and signed by one person with a full handwritten signature and independently checked, dated, and signed by a second person.
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 followed.
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 211.165(b). Microbiological testing Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
21 CFR 211.188. Prepared for each batch, include complete information Batch production and control records are not prepared for each batch of drug product produced and do not include complete information relating to the production and control of each batch.
21 CFR 211.42(c)(1). Incoming material area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the receipt, identification, storage, and withholding from use of components pending sampling, testing, or examination by the quality control unit before release for manufacturing or packaging.
21 CFR 211.68(a). Calibration/Inspection/Checking not done Routine calibration of automatic, mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
21 CFR 211.84(d)(1). Component identity verification Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed.
21 CFR 211.25(a). Training , Education , Experience overall Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training required to perform their assigned functions.
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 211.204. Returned drug procedures in writing and followed Procedures describing the holding, testing and reprocessing of returned drug products are not in writing.
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. 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
Marietta, Georgia, United States. Part of