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FDA establishment 3014759234, Cartersville, Georgia, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 2
Official action indicated: 2
Last inspection ended: Jan 17, 2025
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 2 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 211.84(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 211.160(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 drug products conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.170(b)(1). Retention time of reserve samples, in general You did not retain reserve samples for drug products for one year after the expiration dates of the drug products.
21 CFR 211.22(a). Lack of quality control unit There is no quality control unit.
21 CFR 211.196. Distribution Record Requirements Distribution records do not contain the date and quantity shipped and lot or control number of drug product.
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.
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 211.180(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 211.25(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)
Nov 3, 2023
Drugs · Drug Quality Assurance
8 cited references
21 CFR 211.87. Retest of approved components/containers/closures Approved components, drug product containers and closures are not retested or reexamined as appropriate for identity, strength, quality and purity after storage for long periods with subsequent approval or rejection by the quality control unit.
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 211.165(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 211.160(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, drug product containers, closures, in-process materials, labeling and drug products 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 211.137(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 211.22(a). Lack of quality control unit There is no quality control unit.
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.
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
Cartersville, Georgia, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.