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December 9, 2014

United States

Washington, DC—FDA Warns Foreign Processors on HACCP Rules


In the past month, or so, seafood processors in Ecuador and Vietnam that export shrimp to the USA have received warning letters from the USA Food and Drug Administration (FDA) that say they must adhere to USA’s Hazard Analysis and Critical Control Points (HACCP) rules—or face the possibility of having their products detained at the USA border without any physical examination!


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 provided with a copy of the FDA’s Form-483, which contained inspector observations.  Star Company responded in writing on July 4, 2014, with the corrective measures it planned to take, but the company did not provide FDA with a copy of its HACCP plan.  In its September 24, 2014, warning letter, FDA told the company that it must have a HACCP plan with a hazard analysis for each kind of shrimp product it processed.  Star Company is a processor of wild and farmed shrimp, and FDA said that each of them must be addressed in the HACCP plan.


FDA also inspected Duran-based Crimasa Criaderos De Mariscos, S.A. on June 5-6, 2014.  It is also a processor of wild and farmed shrimp in Ecuador, 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 farmed shrimp products.  FDA’s November 24, 2014, warning letter says the company must address biological, chemical or physical properties that may cause its shell-on farmed shrimp to become unsafe.


In Vietnam, Cau Tre Export Goods Processing Joint Stock Company produces frozen shrimp dumplings, snow crab with garlic butter, frozen shrimp and other fishery products.  FDA said it found HACCP violations at Cau Tre during an inspection conducted on April 14-15, 2014.  The company then provided FDA with documentation on changes, but the warning letter states that those changes have “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.


Warning letters require responses to FDA within 15 days.


Source: (an online, subscription-based, fisheries news service).  Editor and Publisher, John Sackton (phone 1-781-861-1441, email  Seafood Processors From Around the World Receive FDA Warning Letters.  Ken Coons (  December 9, 2014.

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