FDA WARNING_LETTER - DSM Nutritional Products, LLC - February 07, 2019

The FDA, along with the Office of the Texas State Chemist (OTSC), inspected DSM Nutritional Products' animal food manufacturing facility in Fort Worth, TX, on February 6-7, 2019. This inspection was a follow-up to a Reportable Food Registry event where elevated levels of vitamin D3 were found in vitamin and mineral premixes, leading to consumer complaints of ill and deceased dogs. The inspection revealed violations of FDA’s hazard analysis and risk-based preventive controls requirements for animal food (21 CFR part 507, subpart C), rendering products adulterated under the FD&C Act. The primary violation identified was the firm's failure to sufficiently assess the probability of a vitamin D toxicity hazard in the absence of a preventive control. This deficiency was evidenced by two batches of vitamin premix containing vitamin D3 at 2903% and 307% of the claimed amount, respectively, due to human operator error, inadequate secondary review, and lack of a clean-out step between batches. While the firm submitted corrective actions, including ingredient reconciliation, process flow programs, relabeling, and a new preventive control, FDA found the supporting documentation insufficient to evaluate their adequacy. The firm is required to provide a written response within fifteen working days detailing specific corrective steps, recurrence prevention, and supporting documentation, or face potential legal action, including seizure and injunction, and reinspection fees.