FDA warns seafood companies over HACCP violations and potentially adulterated products

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.

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The FDA has issued warning letters to three seafood companies for failing to comply with federal food safety regulations. The violations, stemming from inspections conducted in the past year, raise concerns about hazards such as histamine contamination, pathogen growth, and inadequate supplier verification.

COFISA – Conservas de Peixe da Figueira, S.A.
Portugal

The FDA issued a warning letter on Dec. 18, 2024, to COFISA – Conservas de Peixe da Figueira S.A., a seafood processing facility in Portugal. During an inspection on April 10 and 12, 2024, FDA investigators found multiple violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations.

The agency cited the company’s failure to properly control histamine formation in canned tuna and sardines, a serious risk that can cause scombrotoxin poisoning. 

Key violations included:

• A lack of hazard analysis for Staphylococcus aureus growth during processing.
• Inadequate critical limits at multiple processing points, including temperature monitoring and time controls.
• Deficient corrective action plans, particularly regarding histamine testing.

The FDA determined that COFISA’s products were adulterated under the Federal Food, Drug, and Cosmetic Act because they were processed under conditions that could render them unsafe. The company submitted corrective action plans, but FDA deemed them inadequate. If violations are not addressed, the agency may refuse entry of COFISA’s products into the U.S.

The full warning letter can be viewed here.

Duong Ha Processing Trading Seafood Company Limited
Vietnam

FDA also issued a warning letter on Nov. 26, 2024, to Duong Ha Processing Trading Seafood Company Limited, a seafood processor in Vietnam. The company, which exports frozen vacuum-packaged fish to the United States, was found to be in violation of HACCP regulations following an inspection on July 8-9, 2024.

Key violations included:

• Failure to list a critical control point for unrefrigerated processing, increasing the risk of scombrotoxin (histamine) formation.
• No monitoring of fish temperatures at offloading, a crucial step to ensure histamine levels remain safe.
• Improper labeling for Clostridium botulinum control, which is necessary to prevent botulism in vacuum-packed fish.
• Deficient corrective actions, including failure to properly test fish lots for histamine.

The FDA warned that if the company does not implement effective corrective actions, its products could be subject to detention without physical examination (DWPE), barring them from entering the U.S.

The full warning letter can be viewed here.

Nyumbani Hakuna Matata LLC
Buffalo, NY 

In another case, the FDA sent a warning letter on Dec. 23, 2024, to Nyumbani Hakuna Matata LLC, a seafood importer based in Buffalo, N.Y. The company was previously warned in September 2023 for failing to comply with HACCP importer verification requirements but had not corrected its violations.

During a follow-up inspection on Nov. 13, 2024, the FDA found that Nyumbani Hakuna Matata still lacked supplier verification procedures for imported dried Nile perch, dried Lake Tanganyika dagaa (sprat), and dried migebuka (perch) from Tanzania.

FDA regulations require importers to have:

• Written verification procedures to ensure foreign suppliers comply with U.S. food safety standards.
• Product specifications that outline safety criteria for imported seafood.
• Affirmative steps to verify that foreign suppliers are processing seafood under HACCP-compliant conditions.

Despite the company’s response on Dec. 2 acknowledging the violations, the FDA deemed the response inadequate. The agency warned that failure to comply could result in detention without physical examination of the company’s products and further regulatory action.

The full warning letter can be viewed here.

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Source: https://www.foodsafetynews.com/2025/02/fda-warns-seafood-companies-over-haccp-violations-and-potentially-adulterated-products/