By News Desk | December 8, 2014

Foreign seafood processors in Ecuador, Portugal, Malaysia, Spain and Vietnam have, in the past month or so, have received warning letters from the U.S. Food and Drug Administration (FDA).

All face the possibility of having their fish or fish products detained at the U.S. border without any physical examination unless FDA’s concerns are addressed. And, while the alleged violations differ, almost all involve the U.S. requirement that the processor of fish or fishery products adhere to a specific Hazard Analysis and Critical Control Points (HACCP) plan.


Two seafood processors in Ecuador received warning letters. The Guayaquil-based Star Company S.A. was subjected to FDA inspection last June 2-3, 2014, and was afterwards provided with a copy of the FDA 483 form containing inspector observations.

Star Company responded in writing on July 4, 2014, with corrective measures it planned to take, but the company did not provide FDA with a copy of its HACCP plan.

In the Sept. 24 warning letter, FDA told the company that it must have a HACCP plan with a hazard analysis for each kind of fish or fish product it processes. Star Company is a processor of both wild- and farm-raised shrimp, and FDA said that each of those must be addressed in the HACCP plan.

While in Ecuador, FDA also inspected Duran-based Crimasa Criaderos De Mariscos, S.A. on June 5-6, 2014. It is also a processor of both farm-raised and wild-caught shrimp, and it, too, was provided with the written observations of the inspectors. Crimasa responded in writing on June 27, 2014, but FDA said the responses were not adequate because the company did not revise its HACCP plan to include aquacultured shrimp products.

The Nov. 24 warning letter says the company must address biological, chemical, or physical properties that may cause its farm-raised shrimp on-shell product to become unsafe.

The earliest date for this series of warning letters was Oct. 2, when Gialmar-Produtos Alimentares S.A. was contacted about an FDA inspection of its seafood-processing plant last Feb. 11-12, 2014. The agency was not satisfied with the HACCP plan the Portuguese company provided. An inadequate plan means the company’s fresh and frozen sardines, mackerel, and horse mackerel are adulterated, according to FDA.

Malaysian seafood processor QL Figo Foods SDN BHD received a Nov. 5, 2014, warning letter stemming from an FDA inspection that occurred last May 21, and 22, 2014. Figo provided FDA with written changes to its HACCP plan involving several of its fish and lobster products, but the agency found that the revisions violated HACCP regulations. For example, in its revisions, the Malaysian seafood processor did not take into account the food safety hazard of botulism growth and toxin formation, FDA stated.

FDA also had concerns about temperature controls and monitoring, along with the use of color additives and labeling. It also listed several of the seafood processors’ products that are misbranded.

FDA sent a Nov.  14 warning letter to Spain’s Balfego and Balfego S.L. about the adequacy of its HACCP plan for processing sashimi-grade Bluefin tuna. The company sent a revised HACCP plan to FDA in August after the agency conducted as inspection last April 7-8, 2014.

“Review of the documentation provided by your firm revealed that responses were not adequate as further described in this letter,” the FDA warning states. The agency indicated it viewed the Bluefin tuna produced by Balfeo and Balfeo as adulterated. FDA provided the company with six pages of detailed corrections it is requiring covering temperatures, monitoring, and vessel records, among other topics.

A Ho Chi Minh City seafood processor is the latest of the foreign counties to get an FDA warning letter. Cau Tre Export Goods Processing  Joint Stock Company produces frozen shrimp dumplings, snow crab with garlic butter, frozen shrimp and other fishery products.

FDA stated that it found HACCP violations at Cau Tre during an inspection conducted last April 14-15, 2014.  The company then provided FDA with documentation on changes, but the warning letter states that those changes are “serious deviations” from HACCP regulations.

FDA pointed out that the cooking critical control point suggested by Cau Tre was not sufficient to control pathogen growth and its catching critical control point never insures any checks for heavy metals.

Two domestic seafood processors also received FDA warning letters during November. Detroit-based Sherwood Food Distributors was warned on Nov. 19 about failures with HACCP implementation and inadequate sanitation controls.

Finally, the Hickory Smokehouse of Las Vegas was the subject of a Nov. 14 warning letter about its refrigerated and frozen vacuum-packaged, ready-to-eat hot and cold smoked salmon and trout. The Las Vegas company must address both seafood HACCP and mislabeling concerns, according to FDA.

Warning letters require responses to FDA within 15 days.

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