FDA Issues Warning Letters to Seafood Processors Worldwide

The U.S. Food and Drug Administration (FDA) has sent warning letters to foreign seafood processors in Ecuador, Portugal, Malaysia, Spain and Vietnam over safety concerns. Nearly all the letters involve adherence to a specific Hazard Analysis and Critical Control Points (HACCP) plan, although the alleged violations vary between companies. If the seafood processors do not address the FDA’s concerns, they could have their products detained at the border without any physical examination.

The FDA sent letters to two seafood processors in Ecuador, the Guayaquil-based Star Company S.A. and the Duran-based Crimasa Criaderos De Mariscos, S.A. Both companies are processors of wild- and farm-raised shrimp. The FDA inspected Star Company in June; the agency provided the company with a copy of inspector observations. In July, the company responded to the agency with corrective actions it intended to take, but failed to provide a copy of its HACCP plan. The FDA issued a Sept. 24 warning letter stating that the company must have a HACCP plan with a hazard analysis for each kind of fish or fish product that it processes.

Crimasa Criaderos De Mariscos was also inspected by the FDA in June and also provided with a copy of the inspectors’ observations. The company responded to the FDA later that month, but the agency stated that the responses were insufficient because they failed to revise its HACCP plan to include aquacultured shrimp products. The processor must address biological, chemical, or physical properties that may cause its products to be unsafe, the FDA said in its Nov. 24 warning letter.

The FDA also sent an Oct. 2 warning letter to Portuguese company Gialmar-Produtos Alimentares S.A. over an inspection that took place in February. The agency took issue with the company’s HACCP plan, calling it insufficient; their products are therefore adulterated, the FDA said.
In May, the FDA inspected Malaysian seafood processor QL Figo Foods SDN BHD. The agency issued a Nov. 5 warning letter because the changes the processor made to its HACCP violated regulations. The FDA pointed out, for instance, that the company did not consider the risk of botulism growth and toxin formation. The FDA also took issue with temperature controls and monitoring, the use of color additives and labeling. Additionally, the FDA determined several of the products to be misbranded.

Spain seafood processor Balfego and Balfego S.L. received a Nov. 14 warning letter citing issued with its HACCP plans for processing sashimi-grade Bluefin tuna. The FDA inspected the company in April, and a revised HACCP plan was sent in August.

Recently, the FDA sent a warning letter to Ho Chi Minh City seafood processor Cau Tre Export Goods Processing Joint Stock Company. The company sent in changes to the FDA following an inspection in April, but the agency called the revisions “serious deviations” from HACCP regulations.

Two seafood processors in the United States also received warning letters. The FDA said in a Nov. 19 warning letter that Detroit-based Sherwood Food Distributors failed to properly implement HACCP and had insufficient sanitation controls. The agency sent a Nov. 14 warning letter to Hickory Smokehouse of Las Vegas over its refrigerated and frozen vacuum-packaged, ready-to-eat hot and cold smoked salmon and trout.

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