FDA WARNING_LETTER - Olsen Fish Company - December 11, 2009

On December 7-11, 2009, the FDA inspected Olsen Fish Company in Minneapolis, Minnesota, and found serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). These violations render their pickled herring products adulterated under the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Lack of HACCP Plan:** No HACCP plan for refrigerated ready-to-eat herring in wine and cream sauces to control scombrotoxin (histamine) formation and pathogen growth. 2. **Inadequate Critical Control Points (CCPs):** HACCP plans for Herring in Wine Sauce and Cream Style Pickled Herring do not list packaging as a CCP, despite observations of extended product exposure to elevated temperatures during this step, risking pathogen growth. 3. **Missing Critical Limits:** HACCP plans lack specific maximum values for critical limits at receiving, pre-brine herring, and storage CCPs. The finishing brine CCP for Cream Style Pickled Herring is inadequate for controlling pathogen growth, including *Clostridium botulinum*. 4. **Failure to Implement Record Keeping:** The firm did not record daily visual review/monitoring of time-temperature data loggers at several CCPs as required by their HACCP plans. 5. **Inappropriate Corrective Actions:** Listed