FDA 483 - Golden Shrimp Seafood Joint Stock Company - December 12, 2023

An FDA inspection conducted on December 11-12, 2023, at Golden Shrimp Seafood Joint Stock Company in Tuy Hoa, Vietnam, identified significant issues with the firm's Hazard Analysis and Critical Control Point (HACCP) plan. The primary observation was that the company's monitoring procedures for histamine testing were not adequate to ensure compliance with critical limits. Specifically, the sampling method for histamine detection did not target the lower anterior portion of the fish, where histamine is more likely to be present. Instead, samples were collected from three different areas (back of fin, front of fin, and front of tail). Furthermore, there was a discrepancy between the written procedure for sample size and the actual amount collected. These procedural deficiencies are particularly concerning given the company's recent history, which includes a consumer complaint related to scombrotoxin (histamine) poisoning from tuna in March 2023. Additionally, the firm initiated a product recall in October 2022 due to elevated histamine levels found in frozen yellowfin tuna loin. The inspection also noted the presence of decomposed frozen yellowfin tuna groundmeat. The FDA's findings, reported under Section 704(b) of the Federal Food, Drug and Cosmetic Act, indicate conditions that may render products injurious to health. Golden Shrimp Seafood Joint Stock Company is required to address these observations and submit corrective actions to the FDA.