MiMedx Group, Inc. – FDA 483, Mar 2, 2023

MiMedx Group, Inc. in Marietta, GA, was inspected by the FDA from February 22 to March 2, 2023. The inspection revealed a significant issue with the control over labeling operations, specifically concerning the staging and reconciliation of packaging materials for Axiofill placental collagen matrix products. This indicates a lack of adequate procedures to ensure proper identification and accountability of labeling materials.