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 HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of section 402 (a)(4) of the Federal Food, Drug and Cosmetic Act (the Act), 21 U.S.C. � 342(a)(4).*** Foreign processors who fail to meet ***the*** requirements ***of 21 CFR Part 123*** may have entries subject to detention without physical examination until such time as such documentation demonstrating compliance is provided, as described in "GUIDANCE" section of this import alert. FDA might determine the foreign processor's compliance through inspection of the foreign processor, ***a foreign remote regulatory assessment (FRRA),*** inspection of an importer, review of import entry records, or through review of an importer's seafood product reconditioning proposal.
Fish and Fishery Products
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health in that it appears to have been processed in violation of 21 CFR 123.6(a) and 123.8(a) [Adulteration, 402(a)(4)]. OASIS charge code: MFRHACCP
Divisions may detain without physical examination, fish and fishery products from foreign processors (manufacturers) identified in the Red List to this import alert. Note: Divisions should refer to Compliance Program 7303.0844, "Import Seafood Products" for implementation guidance. Detention Without Physical Examination (DWPE) may be indicated for a foreign processor/product(s) combination when HFP has determined that a foreign processor has failed to meet HACCP requirements for a specific product. DIO will coordinate with HFP for concurrence and addition to the Red List of this import alert. Removal from Detention Without Physical Examination (REMOVE FROM RED LIST): In order to remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrates that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). ***For further guidance on removal from DWPE, refer to FDA�s Regulatory Procedures Manual (RPM), Chapter 9-8, �Detention without Physical Examination (DWPE)�.*** Foreign processors listed on the Red List to this import alert may be removed from that list by submitting documentation demonstrating that they are in compliance with the seafood HACCP regulation (21 CFR, Part 123). The foreign processor should provide a letter detailing its corrective actions, accompanied by documentation. *** Examples of such documentation may include: � HACCP plan � Hazard analysis � Process flow diagram with description of processing steps with times and temperatures � Five days of critical control point monitoring records � Five days of sanitation monitoring records � Procedures � Employee training records � Photographs 21 CFR Part 123 and other resources can be found through links on FDA�s Seafood webpage. For assistance with creating your HACCP plan see Chapter 2 of FDA�s Fish and Fishery Products Hazards and Controls guidance and for sanitation monitoring see the Sanitation Control Procedures for Processing Fish and Fishery Products document. For seafood HACCP training and other resources see the Florida Sea Grant website.*** All relevant information supporting the request should be sent via email to: Importalerts2@fda.hhs.gov Requests for removal from DWPE under the Red List of this import alert will be referred by DIO to Human Foods Program/Division of Produce and Imports Enforcement/Imports Enforcement Branch for evaluation. Questions or issues involving import operations or the submission of petitions for removal from DWPE should be addressed to OII/DIO (301) 796-0356 or Imports@fda.hhs.gov. For technical and scientific questions unrelated to a �live� entry, regarding adequacy of foreign processor HACCP documentation, contact HFP�s Office of Microbial Food Safety, Division of Seafood Safety at (240)402-2300 or via email to: SeafoodHACCP@fda.gov
This alert authorizes Detention Without Physical Examination (DWPE) for products matching this alert. Reason: 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 HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of section 402 (a)(4) of the Federal Food, Drug and Cosmetic Act (the Act), 21 U.S.C. � 342(a)(4).*** Foreign processors who fail to meet ***the*** requirements ***of 21 CFR Part 123*** may have entries subject to detention without physical examination until such time as such documentation demonstrating compliance is provided, as described in "GUIDANCE" section of this import alert. FDA might determine the foreign processor's compliance through inspection of the foreign processor, ***a foreign remote regulatory assessment (FRRA),*** inspection of an importer, review of import entry records, or through review of an importer's seafood product reconditioning proposal.
Country-specific information is available in the full alert detail on the FDA website.
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