FDA 483 - MiMedx Group, Inc. - March 02, 2023

MiMedx Group, Inc. in Kennesaw, GA, received a Form 483 with six observations detailing significant deficiencies in their manufacturing and quality control processes for Axiofill placental collagen matrix. The firm failed to adequately validate its manufacturing process, establish appropriate sampling plans, perform necessary testing for expiration dates and active ingredient identity/strength, and maintain proper documentation for production and component acceptance. These issues indicate a lack of robust controls to ensure product quality, purity, and identity.