AMS Diagnostics, LLC – FDA 483, Jan 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.
ID · 881e97e6-fed7-4086-aca6-b7b9ee2ae969
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