Sen Up Huat Seafood Trading Sdn Bhd – FDA Warning Letter, Oct 24, 2023

On March 6, 2024, the FDA issued a Warning Letter to Ms. Lim of Lot 9999, Jalan Tepi Sungai, Hutan Melingtang, Perak, Malaysia, following an inspection on October 23-24, 2023. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), leading to the issuance of an FDA-483.

The primary violation identified was an inadequate HACCP plan for histamine-forming species, including frozen, raw bonito. Specifically, the plan failed to list adequate critical limits at the receiving critical control point to control histamine formation after capture aboard the harvest vessel. The FDA recommends critical limits such as harvest vessel records for each vessel lot or histamine testing with a limit of less than 50 ppm.

The FDA deemed the firm's November 10, 2023, response and proposed corrective actions inadequate. Consequently, the firm's fresh and frozen histamine-forming seafood products, including bonito, are considered 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 conditions that may render them injurious to health.

The letter warns of potential further actions, including refusal of