FDA 483 - Medegen Medical Products, LLC - May 19, 2023

Medegen Medical Products, LLC in Gallaway, TN, was inspected from May 15-19, 2023, and received a Form FDA 483 with five observations, many of which were repeated from previous inspections. The observations primarily concern inadequate procedures for quality system elements including corrective and preventive actions, acceptance activities, control of non-conforming product, device history records, and complaint handling. These issues indicate significant deficiencies in the firm's quality management system for medical device manufacturing.