FDA WARNING_LETTER - Myllan-ORA ehf - May 25, 2022

On August 30, 2022, the FDA issued a Warning Letter to Vesturvor 12, Kopavogur, Iceland, following an inspection on May 24-25, 2022. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm failed to respond to the FDA-483 Inspectional Observations issued at the conclusion of the inspection.

The FDA determined that the firm's ready-to-eat (RTE) herring and RTE refrigerated lumpfish caviar products are adulterated under section 402(a)(4) of the Federal Food, Drug and Cosmetic Act, as they were prepared, packed, or held under conditions that may render them injurious to health.

Key violations include: 1. **Inadequate HACCP Plan for RTE Refrigerated Lumpfish Caviar:** The HACCP plan lacks critical control points (CCPs) for receiving refrigerated salted caviar (to control *Clostridium botulinum* and *Staphylococcus aureus* toxin formation, requiring a critical limit of 40°F or less and evaluation of water phase salt (WPS) or water activity), refrigerated storage of salted caviar, addition of water/ingredients to lower salt content before filling (requiring a CCP for finished product WPS or water activity), and finished product storage (requiring a CCP of