FDA 483 - DuPont Nutrition USA, Inc - October 25, 2023

An FDA inspection of DuPont Nutrition USA, Inc. in Newark, DE, identified significant deficiencies in quality and laboratory control systems. The firm failed to adequately investigate and close Out-of-Specification events, ensure proper verification of laboratory calculations, and store retained samples under appropriate conditions. Additionally, the handling and recording of customer complaints were found to be inadequate.