FDA WARNING_LETTER - MiMedx Group, Inc. - March 02, 2023

The FDA issued a Warning Letter to MiMedx Group, Inc. on December 20, 2023, following inspections from February 22 to March 2, 2023, at their Kennesaw and Marietta, GA facilities. The inspections documented the manufacture and distribution of AXIOFILL™ (Placental Collagen Matrix), a placenta-derived product intended for topical application to wounds.

The FDA determined AXIOFILL™ is an unapproved new drug and biological product, as it fails to meet the minimal manipulation criterion for HCT/Ps (21 CFR 1271.10(a)(1)) and is not solely regulated under 21 CFR Part 1271. It lacks an approved Biologics License Application (BLA) or an Investigational New Drug (IND) application, violating the FD&C Act and PHS Act.

Furthermore, the inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP) requirements (21 CFR Parts 210 and 211), including: 1. Failure to establish adequate written procedures for production and process control to assure product identity, strength, purity, and quality (21 CFR 211.100(a)). 2. Failure to establish laboratory controls with scientifically sound and appropriate specifications for identity, strength, quality, and purity (21 CFR 211.160(b)).