FDA WARNING_LETTER - ADM Animal Nutrition - March 16, 2023

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