FDA 483 - Advantage Metalwork and Finishing, LLC - February 29, 2024

An FDA inspection of Advantage Metalwork and Finishing, LLC, a medical device contract manufacturer in Rochester, NY, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for controlling nonconforming product, corrective and preventive actions, quality audits, and management reviews. Additionally, issues were noted with calibration procedures, process validation, device master records, supplier controls, and software validation.