MiMedx Group, Inc.

Warning LetterOpen

Joseph H. Capper Chief Executive Officer MiMedx Group, Inc. 1775 W Oak Commons Court NE Marietta , GA 30062 United StatesFEI 3005897621Issued Dec 20, 2023Center for Biologics Evaluation and Research (CBER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3005897621.

Violations10

Issue DateDec 20, 2023

Product TypeBiologics

StatusOpen

Letter Details

Firm: MiMedx Group, Inc.
Location: Joseph H. Capper Chief Executive Officer MiMedx Group, Inc. 1775 W Oak Commons Court NE Marietta , GA 30062 United States
FEI Number: 3005897621
Country: United States
Issue Date: December 20, 2023
Issuing Office: Center for Biologics Evaluation and Research (CBER)
Product Type: Biologics
Status: Open

Summary

MiMedx Group, Inc. was cited for manufacturing and distributing AXIOFILL™, a placental collagen matrix product intended for wound treatment that is classified as both a drug and a biological product subject to Human Cell, Tissue & Cellular Product (HCT/P) regulations under 21 CFR Part 1271. The FDA documented compliance failures during inspections conducted in February-March 2023 at two company locations in Georgia, finding that the product did not meet regulatory requirements for HCT/Ps, including sterility claims and manufacturing standards. The company had distributed the product directly to healthcare facilities across the United States without meeting all applicable regulatory criteria established under section 361 of the Public Health Service Act.

MiMedx Group, Inc. FDA Warning Letter, December 20, 2023