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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.