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Food Processor and Food Manufacturer in Tennessee Put On Notice from the FDA

A seafood processor in Panama and a ready-to-eat food manufacturer in Tennessee are both on notice from the Food and Drug Administration for violations of federal food safety rules.

The FDA sent the warning letters to the companies in July and September and posted them for public view in recent days. 

Companies are allowed 15 working days to respond to FDA warning letters. Failure to promptly correct violations can result in legal action without further notice, including, without limitation, seizure and injunction.

Pesca Fina, S.A. Vista Alegre, Anaijan, Panama 
In a July 18 warning letter to General Manager Constantino Rusodimos, the FDA cited serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation. 

According to the warning letter, the FDA discovered and documented problems during an April 4 inspection of one of the company’s importers in the United States, while assessing that importer’s compliance with the U.S. Seafood HACCP regulation.


“That importer was found to be importing fresh wild caught whole, eviscerated yellowtail tuna, Thunnus Albacares, from your processing facility,” according to the warning letter. 

“During the inspection of that importer, we collected a copy of your firm’s HACCP plan for the fresh wild caught whole, eviscerated yellowtail tuna. Our evaluation of that HACCP plan revealed that the plan demonstrates serious deviations from the requirements of the seafood HACCP regulation.

“Accordingly, your fresh wild caught whole, eviscerated scombrotoxin (histamine) forming fish, including your Mahi Mahi i.e. Dorado, and Yellowtail tuna are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health.”
Upon inspection, the FDA observed the following significant deviations:
  • The firm’s corrective action plans for their “HACCP plan for Whole, Eviscerated Fish, Histamine Producers” at critical control points to control scombrotoxin formation are not appropriate;
  • The firm’s corrective actions do not ensure that adulterated product will remain out of commerce; and
  • The firm does not include a separate critical control point for butchering/packaging, consequently, they will be unable to assess the time/temperature exposures during those steps in their process.
The FDA also requested that the firm’s corrective actions include specification of their HACCP plan for Whole, Eviscerated Fish, Histamine Producers, specifically asking the company to “clarify when you take internal temperatures of fish at the receiving step.”

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