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Foreign Seafood Processors Receive FDA Warning Letters

Dec 9, 2014

In recent months, seafood processors in Ecuador, Portugal, Malaysia, Spain and Vietnam have received warning letters from the U.S. Food and Drug Administration (FDA) about the safety of their products.

The processors face the possibility of having their fish or fish products detained at the U.S. border unless the FDA’s concerns are addressed. The violations alleged in the letters differ but almost all involve the requirement that the processor adhere to a specific Hazard Analysis and Critical Control Points (HACCP) plan to ensure product safety, according to Food Safety News.

Two seafood processors in Ecuador received warning letters after inspections earlier in the year. The Star Company S.A. was inspected on June 2-3, 2014, and received a copy of the FDA inspector’s observations. Star responded in July with corrective measures it planned to take, but did not provide a copy of its HACCP plan. In the Sept. 24 warning letter, the FDA told the company it must have an HACCP plan with a hazard analysis for each kind of fish or fish product it processes. Crimasa Crisderos de Mariscos, S.A. was also inspected in June and the FDA said the company’s HACCP plan was not adequate. The warning letter says the company must address biological, chemical, or physical properties that may cause its farm-raised shrimp in-shell product to become unsafe, according to Food Safety News.

The FDA has also sent warning letters to seafood processors in Portugal, Malaysia, Spain, and Vietnam. The letters cited such safety hazards as botulism growth and toxin formation due to other pathogens. The letters also raised concerns about issues including temperature (in cooking and storage), sanitation, the use of color additives, and instances of product misbranding. The FDA also asked some companies for fishing vessel records. The FDA said a Vietnamese company’s changes represented “serious deviations” from HACCP regulations, according to Food Safety News.

A company must respond to an FDA warning letter in writing within 15 days.

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