An Ecuadorian fish exporter with 20 years in the business could be banned from shipping to the United States, according to an Aug.11 warning letter sent to the company.

The U.S. Food and Drug Administration (FDA) told Emprede SA, based in Guyaquil, Ecuador, that if it does not adequately respond to the warning letter the U.S. might “refuse admission of your imported fish or fishery products…”

FDA has the power to detain shipments of fish and fish products from foreign counties without physical examination.  It can also put a foreign company’s products on “FDA’s Import Alerts” if they are not in compliance with federal seafood Hazard Analysis and Critical Control Point (HACCP) regulations.

The warning, which was recently released, stems from FDA inspection of the seafood processing facility in Ecuador May 5-7.  The agency found “serious violations” of seafood HACCP regulations, involving the company’s escolar, dorado, and histamine fish species.

FDA said these fish were prepared, packed or held under insanitary conditions “whereby they may have been rendered injurious to health.”

Emprede S.A. boasts, “great and modern facilities, next to a meticulous control of quality, position our plant as one of the best in the country,” according to the company’s Website.  It serves markets in the U.S., Europe, and Asia.

However, FDA found its HACCP plan lacking.  It did not contain a critical control point for the refrigerated storage for the histamine species of fish and it did not set critical limits for sampling fish.

In addition, FDA wants the Ecuadorian company to put a consumer warning on the label of its vacuum packaged seafood to make sure it is kept frozen until used.