***Fish and Fishery*** Products from Foreign Processors (Mfrs.) Not in Compliance with Seafood HACCP ***Regulation***

Why FDA issued it

Note: The revision of this Import Alert (IA) dated 01/14/2026 updates the title, reason for alert, and guidance section. Changes to the import alert are bracketed by asterisks (***). ***On December 18, 1997, 21 CFR Part 123 (generally referred to as the seafood HACCP regulation) became effective. Under this regulation, all fish and fishery products, whether foreign or domestic in origin, are required to be prepared, packed and held in facilities operating under mandatory HACCP requirements for safe and sanitary processing. Sanitation controls are to be included within the HACCP plan or monitored in accordance 21 CFR 123.11 (b) to comply with the 21 CFR 123.6 (f). Additionally, compliance with Current Good Manufacturing Practice (CGMP) in 21 CFR 117 is required by 21 CFR 123.5. In accordance with 21 CFR 123.6 (g), failure of a processor of fish or fishery products to have and implement a

Quoted from the “Reason for Alert” section of the FDA page for 16-120, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.