FDA 483 - Gergens Orthodontic Lab, Inc. - March 30, 2023

An FDA inspection of Gergens Orthodontic Lab, Inc., a medical device manufacturer in Phoenix, AZ, revealed a significant lapse in quality system management. The firm was cited for failing to perform quality audits, specifically noting that no internal audits had been conducted since 2019. This indicates a fundamental issue with the firm's quality assurance processes.