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

Source: https://www.globalkeysolutions.net/records/483/dsm-nutritional-products-llc/b4a9868a-d505-4a4a-9c92-862d827504ea

> FDA 483 for DSM Nutritional Products LLC on May 19, 2023. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: DSM Nutritional Products LLC
- Inspection Date: 2023-05-19
- Product Type: other
- Office Name: Minneapolis District Office
- Summary: 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.

## Related Officers

- [Nicholas S. Vasilakes](https://www.globalkeysolutions.net/people/nicholas-s-vasilakes/d6caef48-3adf-45af-80fd-51e1e5c880db)

Company: https://www.globalkeysolutions.net/companies/dsm-nutritional-products-llc/74e1f12b-c885-4fb0-acc6-a589178074b7

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d