FDA WARNING_LETTER - Jensen Tuna Inc - February 15, 2011

On January 27-28 and February 2, 4, 10, 11, and 15, 2011, the FDA inspected Jensen Tuna, Inc.'s seafood processing facility in Houma, Louisiana, revealing serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). These violations render the firm's fishery products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Lack of HACCP Plan:** No HACCP plan for frozen tuna to control *Clostridium botulinum* and metal fragments, despite the product being held under modified atmospheric conditions and using a needle for injection. 2. **Inadequate Hazard Analysis:** The revised "Fresh Tuna" HACCP plan failed to list pathogen growth as a food safety hazard, despite some tuna being sushi-grade and intended for raw consumption. 3. **Missing Critical Control Points (CCPs):** The "Fresh Tuna" HACCP plan, flow chart, and hazard analysis worksheet did not include raw material storage as a CCP for scombrotoxin (histamine) formation and pathogen growth, despite observations of refrigerated whole tuna processing. This also applied to other fish species. 4. **Inadequate Critical Limits:** The "Fresh Tuna" HACCP plan's critical limits at