FDA 483 - MiMedx Group, Inc. - February 04, 2016

An FDA inspection of MiMedx Tissue Services, LLC in Marietta, GA, revealed significant deficiencies in their manufacturing and quality control processes for micronized dHACM products. The firm failed to adequately validate its micronization process, establish appropriate test methods, and maintain proper documentation for production and stability. These issues indicate a lack of assurance regarding the identity, strength, quality, and purity of their drug products.