FDA WARNING_LETTER - El Rey USA Meats & Seafood Inc - January 09, 2026

The FDA issued a Warning Letter to El Rey USA Meats & Seafood Inc. on February 19, 2026, following inspections conducted from January 5-9, 2026. This follow-up inspection revealed serious, repeat violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123, which governs imported fish and fishery products. The company had previously received a letter in January 2023 regarding similar non-compliance after a November 2022 inspection. Key issues identified include the firm"s failure to adequately implement written verification procedures and affirmative steps to ensure imported Tilapia and Shrimp comply with U.S. HACCP requirements. Specifically, their "Preventive Controls Plan" and "Food Safety Plan Receive to Dispatch" lacked written specifications to prevent product adulteration and did not identify the specific affirmative steps being utilized. Furthermore, the "Food Safety Plan Receive to Dispatch" document was not properly signed and dated. Consequently, the imported products were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. El Rey USA Meats & Seafood Inc."s response to the initial inspection findings was deemed inadequate. The FDA requires the company to respond in writing within fifteen working days, detailing specific corrective actions and providing supporting documentation, such as HACCP and importer verification records. Failure to promptly address these violations may result in severe consequences, including the refusal of admission for imported products, detention without physical examination, product seizure, or legal injunctions against the firm.