FDA WARNING_LETTER - Southeast Asian Packaging and Canning Limited.

The FDA issued a Warning Letter to Southeast Asian Packaging and Canning Limited (SEAPAC) after reviewing their HACCP plan and supporting documentation, submitted on January 6, 2014. The review found that SEAPAC's fish and fishery products, specifically pouch-packed tuna, were not in compliance with the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering them adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Significant deviations included: 1. **Inadequate Hazard Analysis:** The HACCP plan for "(b)(4)" tuna did not list *Staphylococcus aureus* growth and toxin formation as a reasonably likely food safety hazard during precooked fish handling (21 CFR 123.6(a) and (c)(1)). 2. **Missing Critical Control Points (CCPs):** The plan lacked CCPs for controlling scombrotoxin (histamine) formation during all holding or storage of fresh tuna after receipt, specifically the "(b)(4)" step (21 CFR 123.6(a) and (c)(2)). 3. **Insufficient Critical Limits:** The plan's critical limits for scombrotoxin control at "CCP II: (b)(4)" and "CCP IV: (b)(4)" were inadequate. For fresh fish, the