DuPont Nutrition USA Inc.

Warning LetterOpen

Mr. Matthew Davidson Plant Manager DuPont Nutrition USA Inc. 1301 Ogletown Rd Newark, DE 19711 United StatesFEI 3013947845Issued Dec 2, 2022Division of Pharmaceutical Quality Operations I

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3013947845.

Violations0

Issue DateDec 2, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: DuPont Nutrition USA Inc.
Location: Mr. Matthew Davidson Plant Manager DuPont Nutrition USA Inc. 1301 Ogletown Rd Newark, DE 19711 United States
FEI Number: 3013947845
Country: United States
Issue Date: December 02, 2022
Issuing Office: Division of Pharmaceutical Quality Operations I
Product Type: Drugs
Status: Open

Summary

DuPont Nutrition USA Inc. was cited for significant current good manufacturing practice (CGMP) violations in the production of Avicel (microcrystalline cellulose), a drug excipient widely used in pharmaceutical formulations. The company failed to adequately investigate approximately 50 complaints received between April 2020 and June 2021 regarding Avicel's failure to meet conductivity specifications established by the U.S. Pharmacopeia, conducting only limited retest and release data reviews rather than thorough root cause analyses. This deficiency rendered the excipient adulterated under federal law for both failure to conform to CGMP requirements and compendial standards for strength, quality, and purity.

DuPont Nutrition USA Inc. FDA Warning Letter, December 2, 2022