FDA 483 - AMS Diagnostics, LLC - January 21, 2020

An FDA inspection of AMS Diagnostics, LLC in Weston, FL, a medical device manufacturer, revealed significant deficiencies in its quality management system. The firm failed to adequately establish and maintain its organizational structure, appoint a management representative, and implement proper management review procedures. Additionally, the inspection found issues with the firm's internal audit program and corrective and preventive action processes, indicating a systemic breakdown in quality oversight.