FDA 483 - DuPont Nutrition USA, Inc - December 13, 2021

An FDA inspection of Dupont Nutrition USA, Inc., an excipient manufacturer in Newark, DE, revealed significant deficiencies across multiple quality system areas. The firm failed to adequately manage changes to procedures, handle customer complaints, investigate out-of-specification results, and maintain complete batch and laboratory records. Additionally, issues were noted with recall procedures and the verification of analytical methods, indicating a broad lack of control over critical manufacturing and quality processes.