FDA 483 - Biedermann Motech, Inc. - November 23, 2022

Biedermann Motech, Inc., a medical device specification developer in Miami, FL, was cited with two observations during an FDA inspection. The firm failed to adequately establish and implement procedures for controlling non-conforming products, specifically regarding documentation for an open nonconformance report. Additionally, the company's complaint handling system was found to be deficient, lacking required second-person reviews for multiple complaint records.