Trang Thuy Seafood Company Limited – FDA Warning Letter, Apr 13, 2023

On November 3, 2023, the FDA issued a Warning Letter to Trang Thuy Seafood Co., LTD, following a Foreign Remote Regulatory Assessment conducted from April 9-13, 2023. This assessment was prompted by a consumer complaint involving histamine poisoning from yellowfin tuna loins, leading to a voluntary recall.

The FDA identified serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). Despite the company's August 16, 2023, response, which included an updated HACCP plan and other documents, the FDA found continued serious concerns. The frozen, vacuum-packed yellowfin tuna is deemed adulterated under Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act), as it was prepared, packed, or held under conditions that may render it injurious to health.

Key violations include: 1. **Inadequate Hazard Analysis and HACCP Plan (21 CFR 123.6(a) and (c)(2)):** The HACCP plan for "Frozen Tuna Treated by CO" (April 25, 2023) fails to list a critical control point to control scombrotoxin (histamine) formation during transport of fresh tuna from the harvest vessel to the processing facility. 2. **Inadequate Monitoring Procedures (21