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.
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