FDA 483 - DSM Nutritional Products LLC - May 19, 2023

DSM Nutritional Products LLC in Arcadia, WI, was cited for a critical deficiency in its HACCP plan for Ready-To-Eat fish oil powder. The plan failed to identify pathogenic bacteria growth and toxin formation, specifically Enterobacter spp., as a reasonably likely food safety hazard. This is a significant concern as the firm repeatedly released product with positive Enterobacter spp. tests, and the product is used in various RTE human foods, including infant formula.