FDA WARNING_LETTER - Golden Shrimp Seafood Joint Stock Company - December 12, 2023

The FDA inspected a seafood processing facility in Tuy Hoa, Phu Yen, Vietnam, on December 11-12, 2023, following a consumer complaint of histamine poisoning from yellowfin tuna. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), resulting in a Form FDA-483. The firm's responses on December 22, 26, and 27, 2023, including corrective actions and updated raw ingredient sampling procedures for histamine, were deemed inadequate.

Specifically, the HACCP plan for "Frozen Yellowfin Tuna CO/TS Treated, Cut into Loin, Saku, Cube, Steak, Strip, Crazy, Portions," dated September 25, 2022, lacked adequate critical limits at the critical control point for scombrotoxin (histamine) formation. The listed critical limit for sampling was insufficient to ensure representativeness, and no critical limit was listed for when fish are offloaded from harvest vessels. Although the firm updated sampling procedures, an updated HACCP plan incorporating these changes was not provided, preventing evaluation of their adequacy.

Consequently, the firm's frozen histamine-forming yellowfin tuna products are considered adulterated under section 402(a)(4) of the Federal Food, Drug and Cosmetic Act. The firm is already on the "Red List" of Import