FDA 483 - Vaupell Midwest Molding and Tooling - March 04, 2022

An FDA inspection of Vaupell Midwest Molding and Tooling, a medical device manufacturer in Constantine, MI, revealed significant deficiencies in their corrective and preventive action procedures. The firm failed to adequately establish requirements for analyzing quality data to identify causes of nonconforming products or other quality problems. This indicates a lack of robust quality system controls.