FDA WARNING_LETTER - Pacific Food, Inc - February 25, 2011

The FDA inspected a seafood processing facility in Columbus, OH, from February 18-25, 2011, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's sushi products were deemed adulterated due to insanitary conditions. Additionally, the Spicy Shrimp Roll product was found to be adulterated due to an unsafe color additive and misbranded.

Key violations include: 1. **HACCP Plan Deficiencies:** The sushi roll HACCP plan failed to list pathogen growth and toxin formation as a hazard at the finished product storage critical control point, only addressing histamine development. 2. **Missing Critical Control Point:** The HACCP plan did not include a critical control point for thawing/storage of frozen vacuum-packed tuna to control histamine formation and *Clostridium botulinum* growth and toxin formation. 3. **Inadequate Monitoring Procedures:** The monitoring frequency for finished product storage (beginning and end of storage) was insufficient to control histamine formation and pathogen growth/toxin formation. Continuous monitoring was recommended.

Labeling violations for the Spicy Shrimp Roll product included: 4. **Undeclared Allergen/Unsafe Color Additive:** Failure to declare carmine, a color additive and allergen, in the ingredient statement, rendering the product misbranded and adulterated. 5. **Incomplete Ingredient Declaration:**