FDA 483 - MiMedx Group, Inc. - December 12, 2019

MiMedx Group, Inc. in Marietta, GA, a human tissue and biologic drug manufacturer, was cited with nine observations during an FDA inspection. The findings indicate significant deficiencies across multiple areas, including inadequate product release testing, failure to report adverse drug experiences, insufficient employee training, compromised equipment integrity, and widespread contamination risks. Additionally, the firm exhibited poor control over laboratory data, in-process manufacturing, and environmental monitoring in aseptic areas.