Four seafood processing facilities — making everything from herring and mackerel to raw trout, whitefish and walleye to seafood stuffings and salads — received warnings letters from the U.S. Food and Drug Administration (FDA) in early August.


In an Aug. 2 warning letter, FDA advised Lewiston, ME-based Deshales’ Associates Inc. of  “serious violations” of seafood Hazard Analysis and Critical Control Point regulations and misbranding.

Regarding the seafood HACCP violations, the warning letter says the Maine seafood processor did not have a plan for its seafood stuffing product to control the food safety hazards of pathogen survival through cooking, pathogen growth and toxin formation –including Staphylococcus aureus and Clostridium botulinum — and allergens and food intolerance substances.

For its seafood salad product, the processor did not list critical control points for controlling the food safety hazard of pathogens, specifically Clostridium botulinum growth and toxin formation, and during finished product storage to declare incorporated allergens, FDA said.

At the Lewiston seafood processing facility, inspectors also observed poor sanitation conditions and practices, including:

— dried food residue along the front and side edges of the scale used for weighing food

— rust, dried food residue and flaking paint on the lobster meat

— an employee wearing long sweatshirt sleeves extending beyond the apron was touching the rim of the mixing tray

— an employee went outside wearing an outdoor coat over her apron and later returned without changing, cleaning or sanitizing the apron

FDA also said the processor temperature monitoring and corrective action plan for controlling growth of pathogenetic bacteria required improvements.

On branding, the processor did not declare crab as a major food allergen nor other ingredients that contain other allergens.

On Aug. 8, FDA sent a warning letter to Sivertson Fisheries Inc. in Superior, WS.  The company, doing business as the Lake Superior Fish Company, was also informed of its “serious violations” of seafood HACCP regulations.

Lake Superior processes pickled herring and air-packed, ready-to-eat smoked fish products and raw trout, whitefish, herring and wallet fillets.  FDA said those products were being “prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.”

The warning letter says mice and insects were found in the facility.  Smelt dressing machines had debris on their conveyor lines, and they had not been recently cleaned. 

Lake Superior had neither closed points of entry for pests nor eliminated their harborage areas, including areas of clutter and old equipment both inside and outside the facility.

In addition to several other concerns about the adequacy of its seafood HACCP plan, FDA said the company’s existing corrective action plan was not adequate to control pathogen growth and histamine formation.

Carteret, NJ-based Porky Products Inc., which makes salted smoked split herring, vacuum packed back-split mackerel fillets in brine, and pickled back-split mackerel, received an Aug. 8 warning letter from FDA over its imported products.

Porky Products imports from Canada.  It says it only imports from establishments approved for export to the U.S. on a list maintained by the Canadian Food Inspection Agency (CFIA).  FDA said Porky Products still must maintain records demonstrating approval existed at the time of import.

FDA said Porky does not have a seafood HACCP plan for its vacuum-packed product and does not address the food safety hazards of histamine  and pathogen growth and toxin formation.

The warning letter also expresses concern about the temperature of product at the time it is received after a shipment time that exceeds four hours.  FDA says Porky must demonstrate the product is kept at 40 degrees or less to prevent pathogen growth.

The Dockside Fish Market in Grand Marais, MN received an Aug. 11 warning letter that said its existing seafood HACCP plan does not list the food safety hazard of histamine associated with smoked herring and undeclared allergens associated with all finish products.

Dockside also failed to list time and temperature controls as critical limits and did not list a critical limit for the brining process.  FDA also said monitoring procedures and their frequency were not adequate to control pathogen growth and toxin formation.

FDA also detailed how cooling should be handled, and said the company had no plan for fresh and frozen raw herring, whitefish and lake trout.

The four seafood processors subject to warning letters between Aug. 2 and 11 were each given 15 working days to respond to FDA with information on how violations are being addressed.