FDA 483 - Biedermann Motech, Inc. - October 15, 2019

An FDA inspection of Biedermann Motech, Inc., a specification developer and contract manufacturer based in Miami, FL, was conducted from October 4 to October 15, 2019. The inspection resulted in five observations of deficiencies in the firm's quality system, indicating areas needing improvement to ensure compliance with medical device regulations. Key issues identified include the inadequate validation of manufacturing processes. Specifically, the firm failed to validate cleaning instructions for instrument Instructions for Use (IFU) and did not perform process validation for software-operated lathing and CNC milling steps used to produce Class 2 device instruments. Design validation procedures were also found to be insufficient, as a study for an Injection Screw lacked a clear methodology, and user instructions were not adequately addressed to meet user needs. Furthermore, the inspection noted that certain software-controlled measuring and test equipment used for finished product quality testing was not validated for its intended purpose. The company also failed to ensure incoming metal components met specified industry standards. Lastly, procedures for monitoring purchased products and services were not consistently followed, as a vendor performance review for a contract manufacturer was incomplete yet approved. Biedermann Motech, Inc. is expected to address these observations by implementing comprehensive corrective actions and ensuring robust quality system adherence to meet regulatory requirements.