FDA WARNING_LETTER - STARKIST CO.

The FDA issued a Warning Letter to StarKist (Ecuador) following a review of their Hazard Analysis and Critical Control Point (HACCP) plan and supporting documentation for canned, pouch-packed, and frozen loin tuna products, submitted on May 13, 2014. The evaluation revealed serious deviations from the seafood HACCP regulation (21 CFR Part 123), rendering their tuna products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Hazard Analysis:** The HACCP plan failed to list metal inclusion as a reasonably likely food safety hazard, despite acknowledging its potential presence. 2. **Inadequate Critical Limits:** Critical limits at CCP 4A (scombrotoxin formation) and CCP 4B (Staphylococcus aureus toxin formation) were insufficient, as time limits did not account for all temperature exposures contributing to cumulative abuse or continued incubation until inhibitory conditions were reached in packaged products. The "start of freezing process" was also unclear. 3. **Inadequate Monitoring Procedures:** At CCP 1 (receiving), histamine sampling and testing were inadequate, with only (b)(4) samples for (b)(4) of incoming fish, and combining all light meat tuna species for testing. 4. **Inadequate Corrective Action Plans:** Corrective actions at CCP 4A and CCP 4