Three seafood processors, one seafood importer, and a seafood restaurant in California, Texas and New York, are all 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 June and October, 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.

In two of the five warning letters, the FDA acknowledged the Texas seafood processor’s, and the New York seafood importers’ promised corrective actions. Yet, both responses were determined “insufficient” to meet the expected corrective actions, according to the FDA warning letters.

Performance Food Group Inc. McKinney, TX 
In an Oct. 12 warning letter to president and CEO Craig H. Hoskins, the FDA cited serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, and the Current Good Manufacturing Practice (CGMP) regulation for food. The FDA discovered and documented problems at the McKinney, TX, seafood warehouse between Aug. 15 and 21.

“Accordingly, your ready-to-eat, canned, pasteurized crabmeat is adulterated, in that it has been prepared, packed, or held under conditions whereby it may have been rendered injurious to health,” according to the warning letter.

Upon inspection, the FDA observed the following significant deviations:

  • The firm did not take a corrective action to control the significant hazards of C. Botulinum and pathogen growth by deviating from its HACCP plan’s critical limit at the Receiving CCP, specifically regarding their written HACCP plan for pasteurized crabmeat that states the product will be maintained at 40 degrees F or colder during transit.
  • On July 14, the firm’s time/temperature indicator record showed that the ambient temperature of the transportation trailer exceeded the critical limit of 40 degrees F for approximately 16 hours with a high temperature mark of approximately 43 degrees F: “Your firm received the shipment of pasteurized crabmeat without conducting a time/temperature assessment and without conducting a corrective action. The product was later distributed into commerce.”
  • On July 20, the firm’s time/temperature indicator record showed that the ambient temperature of the transportation trailer exceeded the critical limit of 40° degrees F for approximately 72 hours with a high temperature mark of approximately 45 degrees F: “Your firm received the shipment of pasteurized crabmeat without conducting a time/temperature assessment and without conducting a corrective action. The product was later distributed into commerce.”

The FDA recommended the firm’s corrective actions should include discontinuing use of the carrier until evidence is obtained that transportation and handling practices have been improved. 

Nathan’s Soup and Salad Henrietta Inc. Rochester, NY 
In an Oct. 11 warning letter to owner Richard M. Torcello, the FDA cited serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation. The firm processed fish/fishery products for their soups and ready-to-eat (RTE) salads. The FDA discovered and documented problems at the Rochester, NY manufacturing facility between Aug. 21 and 25.

“Accordingly, your refrigerated, New England Clam Chowder is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health,” according to the warning letter.

According to the warning letter, the FDA observed several significant deviations. The firm does not have a HACCP plan for its refrigerated “New England Clam Chowder” to control the food safety hazards of pathogen growth, and pathogen survival through cooking or pasteurization. This also includes the firm’s lack of HACCP plan hazards of toxin formation, including Clostridium botulinum due to time/temperature abuse.

“You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur,” FDA officials said in the warning letter.

Smoked Seafood Inc. dba Little Mermaid Smokehouse, North Hollywood, CA 
In a June 27 warning letter to co-owners Manik Mona Saakyan and Saak (Sam) Saakyan, the FDA cited misbranding violations for several of the firm’s products.

“Based on our review, we have determined that your Little Mermaid Smoke House Salmon/Kapitan, Little Mermaid Smoke House Seafood Croissant, Little Mermaid Smoke House Smoked Salmon Trout, Little Mermaid Smoke House Smoked Gorbusha, and Little Mermaid Smoke House Balik/Kapitan products (henceforth referred to as Salmon/Kapitan, Seafood Croissant, Smoked Salmon Trout, Smoked Gorbusha, and Balik/Kapitan, respectively) are misbranded,” according to the warning letter.

The FDA discovered and documented problems at the North Hollywood, CA seafood processing facility between Nov. 29 and Dec. 19, 2017.

Upon inspection, the FDA observed the following significant misbranding violations:

  • The firm’s Salmon/Kapitan, Seafood Croissant, Smoked Salmon Trout, Smoked Gorbusha, and Balik/Kapitan products are manufactured with fish, a major food allergen; however, fish is not properly declared by the species of fish or crustacean shellfish.
  • The firm’s products refer to steelhead trout as gorbush, escolar as kapitan, and sturgeon as balik. However, these are not appropriate names for the respective species of fish and, therefore, their product labels do not properly declare the following major food allergens specified by the Act.
  • Furthermore, these products also fail to provide nutrition labeling, “No evidence has been provided to indicate that your firm or products meet any nutrition facts labeling exemption criteria.”

The FDA also noted the firm’s Seafood Croissant product contains “crab imitation” as an ingredient. It is misbranded because the product label does not list the component ingredients for the “crab imitation” ingredient, which is understood to be a multicomponent ingredient.

Other violations noted in the warning letter include:

  • Products appear to use foreign names on labels. If the name of the food is intended to bring the article to the attention of a person who does not speak English, all required information must be presented in the foreign language;
  • Salmon/Kapitan, Seafood Croissant, Smoked Salmon Trout, and Smoked Gorbusha products declare “Natural Smoke” in the ingredient declaration while your Balik/Kapitan product declares “Natural Smoke flavor” in the ingredient declaration. If these smoke ingredients are added flavors, they should be declared, however, if these ingredients describe the smoking process, then they must not be listed as ingredients in the ingredient statement;
  • Salmon/Kapitan, Seafood Croissant, Smoked Salmon Trout, Smoked Gorbusha, and Balik/Kapitan products do not provide the place of business street address on product labels; and
  • Seafood Croissant and Balik/Kapitan products declare kosher salt as an ingredient with the word “KOSHER” appearing in larger type than other ingredients. The intent of this formatting is not clear. Declarations made on your label must not be misleading.

Estiatorio MilosNew York City 
In an Oct. 4 warning letter to CEO and owner Costas Spilliadis, and co-owners George Spilliadis and Evridiki Spilliadis, the FDA cited serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.

The firm’s fresh farm-raised sea bream and fresh farm-raised meagre, fresh sardines, ready-to-eat salt-cured grey mullet roe bottarga, and fresh farm-raised sea bass are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. The FDA discovered and documented problems at the New York City seafood importer’s establishment April 27 and 28.

“There must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors, the fish or fishery products will appear to be adulterated and will be denied entry,” according to the FDA warning letter.

“You must implement an affirmative step which ensures that the fish and fishery product(s) you import are processed in accordance with the seafood HACCP Regulation.” However, the firm did not perform an affirmative step for any of the adulterated products.

The FDA noted it had reviewed the firm’s response, but explained it was not adequate because, “the documentation submitted with your response, including the certificates, do not provide assurance that the fishery products you import are processed in accordance with the requirements of the U.S. FDA seafood HACCP regulation.”

Masa restaurant, New York City 
In an Oct. 16 warning letter to restaurant partners Masayoshi Takayama and Catherine Takayama, the FDA cited serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation. As a seafood establishment, the restaurant imports fish or fishery products. The FDA discovered and documented problems at the New YorkCity restaurant on June 22.

“Your fresh trevally and fresh Katsuwonus pelamis (Katsuo), also known as skipjack tuna or bonito, are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health,” according to the warning letter.

“There must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors, the fish or fishery products will appear to be adulterated and will be denied entry.

“You must implement an affirmative step which ensures that the fish and fishery product(s) you import are processed in accordance with the seafood HACCP Regulation.” However, the firm did not perform an affirmative step for its skipjack tuna or bonito.

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