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 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.”

Demetri’s Coffee Chattanooga, TN
In a Sept. 25 warning letter to owner Demetri S. Proffitt, the FDA cited serious violations of the FDA’s Current Good Manufacturing Practice (cGMP) requirements in Manufacturing, Packing or Holding Human Food. The firm manufactures ready-to-eat (RTE) food products for catering operations. The FDA discovered and documented problems at the Chattanooga, TN, manufacturing facility between July 17 and 19.

The conditions observed cause the food products held at the facility to be adulterated because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health.

According to the warning letter, the FDA observed the following significant deviations:

  • The firm failed to hold foods which can support the rapid growth of undesirable microorganisms at a temperature that prevents the food from becoming adulterated. Shelled eggs, uncooked biscuit dough, cheese, gravy and other ingredients were stored in the produce cooler at approximately 60.4 degrees Ft. Some of the tubes of uncooked biscuit dough had expanded outside their packaging, some of which were observed touching the walls of the cooler.
  • The firm failed to comply with the requirement that all people working in direct contact with food, food-contact surfaces and food-packaging materials wash their hands thoroughly and sanitize if necessary to protect against contamination in an adequate hand washing facility before starting work, after each absence from the work station, and at any other time their hands may have become soiled or contaminated.

“Specifically, on July 7, three employees changed their gloves without washing their hands when they changed the type of meat during manufacturing for various ready-to-eat sandwiches,” according to the warning letter.

“Furthermore, the same employees touched non-food contact surfaces, left the room and returned to manufacture ready-to-eat sandwiches without washing their hands.

“Additionally, an employee touched her face several times with a gloved hand and then directly touched ready-to-eat food without washing her hands and/or changing gloves.”

  • The firm failed to take effective measures to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests. Live flies were observed in the production room landing on ready-to-eat sausage biscuit sandwiches and food contact surfaces throughout the inspection. On two two different days, live cockroaches were observed on a food processing table leg and crawling on the walls, ceiling and floor.
  • Employees failed to wear outer garments suitable to the operation in a manner that protects against the contamination of food, food-contact surfaces, or food-packaging materials. An employee who was not wearing an apron was observed to be making ready-to-eat egg and cheese croissant sandwiches when the top of the croissant fell onto the employee’s shirt. The employee placed the top of the croissant back onto the sandwich and packaged it for sale.
  • Floors were observed to have apparent filth, grime, and food debris before and after sanitation practices were performed and condensate was observed dripping from cooling units and ceilings in the bread cooler onto various packaged bread, packaging materials, batter and products used to manufacture ready-to-eat foods.
  • The firm failed to properly maintain plant equipment as to be adequately cleanable and properly maintained. Wooden tables with visible seams and cracks were observed being used to prepare a variety of sausage biscuit sandwiches, burgers, and other food.
  • The firm failed to have adequate drainage of areas which may contribute to contamination of food by seepage, foot-borne filth, or by providing a breeding place for pests.
  • The firm failed to store clothing or other personal belongings in areas other than where food is exposed or where equipment or utensils are washed.
  • The firm’s employees failed to wear, where appropriate, in an effective manner hair nets, headbands, caps, beard covers, or other effective hair restraints.


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