Hong Ngoc PTE – FDA Warning Letter

The FDA issued a Warning Letter to Mr. Tran Thi HONG NGOC PTE. following a review of their HACCP plans and monitoring records for fish and fishery products imported into the United States, specifically "Tuna Cut CO Treated Frozen" and "Freshness Tuna Fillet." The review, based on documents provided on June 17, 2013, revealed serious deviations from the seafood HACCP regulation (21 CFR Part 123), rendering the tuna products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to list Clostridium botulinum toxin formation as a food safety hazard** in HACCP plans for "Tuna Cut CO Treated Frozen" (due to reduced oxygen environment during CO treatment) and "Freshness Tuna Fillet" (for refrigerated vacuum-packaged product). Recommendations include maintaining temperatures below 3.3°C, continuous monitoring, and appropriate labeling. 2. **Failure to list critical control points for scombrotoxin (histamine) formation**, specifically at receiving (offloading from harvest vessel) and during unrefrigerated processing steps. 3. **Inadequate critical limits** for decomposition (less than 2.5% decomposition recommended for sensory examination), harvest vessel records (e.g., fish placed in cooling medium within 9 hours of death if air/water exposure is 83