# FDA WARNING_LETTER - DuPont Nutrition USA Inc. - December 15, 2021

Source: https://www.keypedia.com/records/warning_letter/dupont-nutrition-usa-inc/07e03024-2e98-498c-a8c2-3558ce4bcacd

> FDA WARNING_LETTER for DuPont Nutrition USA Inc. on December 15, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: DuPont Nutrition USA Inc.
- Inspection Date: 2021-12-15
- Product Type: Drugs
- Office Name: Division of Pharmaceutical Quality Operations I
- Summary: The FDA issued a Warning Letter to DuPont Nutrition USA Inc. following a November-December 2021 inspection of their Newark, Delaware facility, citing significant CGMP deviations in the manufacture of the excipient Avicel. Avicel, a major component in drug products, was deemed adulterated under sections 501(a)(2)(B) and 501(b) of the FD&C Act due to non-conformance to CGMP and compendial standards (USP) for conductivity.

Key violations include:
1. **Inadequate Complaint Investigations:** Approximately 50 complaints regarding Avicel's failure to meet conductivity specifications were not adequately investigated. A malfunctioning conductivity meter probe, discovered seven months later, was linked to OOS results, but customers were not timely notified (over three months delay).
2. **Insufficient OOS Investigations:** Failing conductivity results were inadequately investigated, lacking thorough root cause analysis, expansion to affected lots, and timely CAPA implementation. Elevated ammonium chloride levels were identified as a root cause, raising concerns about nitrosamine formation.
3. **Unsuitable Test Methods:** Compendial and non-compendial conductivity test methods lacked adequate verification and validation. Discrepancies were found in method verification, and a non-compendial method, despite poor correlation, was used for release testing, potentially leading to the release of OOS Avicel. Inappropriate composite sampling further exacerbated this.
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## Related Officers

- [Director of Investigations Branch](https://www.keypedia.com/people/nerizza-guerin/407df995-bd23-4948-82c2-e3bf8a6659b7)

Company: https://www.keypedia.com/companies/dupont-nutrition-usa-inc/61f33c30-982d-4652-9b1f-3e64c68ea66f

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-i/6ded4818-ee3a-46a1-84c1-36de58502b02