# FDA WARNING_LETTER - ADM Animal Nutrition - March 16, 2023

Source: https://www.keypedia.com/records/warning_letter/adm-animal-nutrition/5bf8d74f-6ced-4b47-8876-9881972a6576

> FDA WARNING_LETTER for ADM Animal Nutrition on March 16, 2023. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: ADM Animal Nutrition
- Inspection Date: 2023-03-16
- Product Type: Food
- Office Name: Division of Human and Animal Food Operations - East VI
- Summary: The FDA issued a Warning Letter to a vitamin and mineral premix and preblend animal food manufacturing facility in Effingham, IL, following a March 13-16, 2023, inspection. The inspection was prompted by a Class I recall initiated by a customer due to elevated vitamin D levels in dry dog food, leading to consumer complaints of illness. The facility also filed Reportable Food Registry reports for elevated vitamin D in its AA Diet preblend.

The FDA found a significant violation of 21 CFR Part 507 (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals), rendering products adulterated. Specifically, the firm failed to sufficiently assess the probability of vitamin D nutrient toxicity in the absence of preventive controls, relying on insufficient prerequisite programs. Despite identifying vitamin D toxicity as a high-severity hazard, the firm's prerequisite programs, including (b)(4), failed to prevent the incorrect addition of ingredients, as evidenced by the elevated vitamin D levels in the AA Diet preblend.

The firm's responses dated April 6, 14, and 20, 2023, acknowledged the failure of prerequisite programs and stated the implementation of a new process preventive control for vitamin D hazards, including designated storage for high-risk vitamin D ingredients and a (b)(4) system. However, the FDA could not fully evaluate these corrective actions due to a lack of documentation demonstrating their implementation

## Related Documents

- [OTHER_CORRESPONDENCE - 2018-11-28](https://www.keypedia.com/records/other_correspondence/adm-animal-nutrition/69eecb80-00f1-4b99-b2dc-2f11819eb102)

## Related Officers

- [Program Director](https://www.keypedia.com/people/william-r-weissinger/4b648d9e-90cc-48e9-9bac-f782bed02d89)

Company: https://www.keypedia.com/companies/adm-animal-nutrition/61422f4f-1329-4813-9271-a970e67a4ee6

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-vi/4a1cadca-f04c-44d0-8d7a-4e1d6e583766