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FDA establishment 3009814715, Kennesaw, Georgia, United States. Part of MiMedx Group'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: Mar 2, 2023
Warning letters: 1
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.
Biologics · Vaccines and Allergenic ProductsBiologics · Human Cellular, Tissue, and Gene Therapies
6 cited references
21 CFR 211.100(a). Absence of Written Procedures Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.84(d)(2). Component identification test Specific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis.
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 211.166(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 211.165(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.
Official Action Indicated (OAI)
Dec 12, 2019
Biologics · Human Cellular, Tissue, and Gene Therapies
14 cited references
21 CFR 1271.270(a). Records incomplete Records did not identify the person performing the work and were not detailed as necessary to provide a complete history of work performed.
21 CFR 211.100(b). SOPs not followed / documented Written production and process control procedures are not followed in the execution of production and process control functions.
21 CFR 211.42(c)(10). Aseptic Processing Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.
21 CFR 211.42(c)(10)(iv). Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
21 CFR 211.165(f). Failing drug products not rejected Drug products failing to meet established specifications are not rejected.
21 CFR 211.25(a). Training , Education , Experience overall Employees engaged in the packing of a drug product lack the education and training required to perform their assigned functions.
21 CFR 211.113(b). Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
21 CFR 1271.180(a). Procedures to meet core CTGP Procedures appropriate to meet core CGTP requirements for all steps that you perform in the manufacture of HCT/Ps were not followed.
21 CFR 1271.160(b)(6). Deviations--evaluation, cause, corrective action Investigation of deviations related to core CGTP requirements did not include a review and evaluation of the deviation, efforts to determine the cause of the deviation and corrective action(s) to address the deviation and prevent recurrence.
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 and cleaning and maintenance.
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 1271.220(c). Specified requirements for in-process controls Specified requirements for in-process controls were not met.
21 CFR 211.82(b). Quarantine Storage of Components Incoming drug product containers and closures are not stored under quarantine until they have been tested or examined, as appropriate, and released.
Voluntary Action Indicated (VAI)
Sep 26, 2018
Biologics · Human Cellular, Tissue, and Gene Therapies
None posted
No Action Indicated (NAI)
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
Kennesaw, Georgia, United States. Part of