FDA WARNING_LETTER - Trans-Pacific Assets Management Inc. - August 03, 2012

On September 5, 2012, the FDA issued a Warning Letter to Trans-Pacific Assets Management Inc. following an inspection from July 23 to August 3, 2012, at their Hayward, California facility. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123, specifically 21 CFR 123.12, concerning imported fish and fishery products.

The FDA found that the firm's imported products, including Sardines in Tomato Sauce, Mackerel in Natural Oil, and Dried Herring with Garlic in Olive Oil from the Philippines, were adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)), as they were prepared, packed, or held under insanitary conditions.

Significant violations included: 1. **Lack of Product Specifications (21 CFR 123.12(a)(2)(i)):** The firm failed to have product specifications for Sardines in Tomato Sauce and Mackerel in Natural Oil to address hazards such as histamine, undeclared food allergens, and potential metal and glass inclusion. For Dried Herring with Garlic in Olive Oil, specifications were also missing for potential *Staphylococcus aureus* toxin formation. 2. **Failure to Implement Affirm