FDA issues final warning of the year to seafood processor

Published on
January 11, 2016

The last warning letter sent out by the U.S. Food and Drug Administration (FDA) for 2015 was postmarked to a seafood processor, Eco Sushi Express Inc. out of Oakville, Conn.

According to the letter, the agency found “serious violations” of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations after conducting a routine inspection of the Eco Sushi Express seafood processing facility 9-10 September, as well as 15 September. Fish and fish products from the facility, such as its ready-to-eat sushi rolls, are “adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health,” reported the FDA.

Authorities find that Eco Sushi is in violations of current Good Manufacturing Practices (cGMP), adulteration and misbranding regulations in particular, which involves the monitoring of procedures, listing critical limits in the seafood processor’s HACCP and maintaining sanitation control records, reported Food Safety News.

“Also, there are no periodic (monthly) sanitation monitoring reports to document the safety of water, condition of food contacts surfaces and prevention of cross contamination,” the FDA said in its warning letter.

Because they allegedly contain the unsafe food additive Phenylalanine, an amino acid, the agency said that Eco Sushi’s products such as its “Spicy Tuna,” “Spicy Salmon,” “Spicy Shrimp,” and “Spicy Combo,” are all adulterated. What’s more, “Spicy Shrimp” and “Spicy Tuna” sushi roll products have been misbranded, said the FDA – eggs are not listed on the packaging as a major food allergen.

The processor may also be formatting its listing of nutritional information incorrectly. However, if production is less than 100,000 units a year, sold in the United States, or it Eco Sushi employs fewer than 100 full time employees a year, the products could be exempt from this violation.

Other comments relayed by the FDA to Eco Sushi in its letter include:

  • The “Spicy Tuna,” “Spicy Shrimp,” and “Spicy Combo” product labels bear a “may contain” statement which is an “advisory statement. This statement could cause confusion to the consumer when purchasing the products since these products do in fact contain many of these major food allergens.
  • The “Vegetable Combo” product label declares “wheat” in the “Contains” statement; however, fails to declare wheat in the ingredient statement. The “Contains” statement must be adjacent to the ingredient statement.
  • The “Spicy Salmon” product label declares fish, egg, soy, and wheat in the “Contains” statement; however, fails to declare these ingredients in the ingredients statement. The declaration of “fish” does not meet the requirements under FALCPA. The “Contains” statement must be adjacent to the ingredient statement.
  • Your products are identified on the labels as “Vegetable Combo,” “Spicy Tuna,” “Spicy Shrimp,” and “Spicy Combo;” however, you fail to include “roll” or “sushi roll.”
  • For your “Spicy Combo” product, it is unclear as to whether or not all of the types of named sushi are packaged with this labeling at all times. If the product does not contain all four varieties at all times, then the name of the product would not clearly represent what is in the package.

The letter, which was sent out on 29 December, gave Eco Sushi 15 days to respond to the agency’s claims.

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