FDA 483 - DSM Nutritional Products, LLC - June 12, 2025

The FDA inspected DSM Nutritional Products, LLC from June 9-12, 2025, issuing a Form 483 detailing significant observations regarding the firm's food safety plan. This document, issued under the Federal Food, Drug, and Cosmetic Act, indicates practices that may lead to adulterated products.

Key violations include the absence of identified and implemented preventive controls for mycotoxins, a recognized hazard in macro ingredients used for various animal feeds. The company's food safety plan lacked a written program for mycotoxins, and there were no monitoring or verification procedures, including product testing, to confirm control.

Furthermore, the inspection revealed inadequate verification of preventive controls for vitamin toxicity/deficiency and dioxin in copper sulfate. While some corporate pre-requisite programs were in place, the Pendergrass facility did not routinely test a full range of vitamins and minerals in raw ingredients or finished products. Existing product testing procedures for certain compounds were incomplete, lacking details on sample identification, sampling frequency, analytical methods, and the testing laboratory. Similarly, despite recognizing dioxin as a hazard in copper sulfate and requiring supplier certificates, the facility performed no independent verification testing.

To rectify these issues, DSM Nutritional Products, LLC must develop and implement comprehensive written preventive controls for all identified hazards. This includes establishing and executing robust monitoring and verification procedures, such as routine product testing of raw materials and finished products, and ensuring all testing procedures are thoroughly documented to confirm the consistent effectiveness of these controls.