In the letter sent on Dec. 29, FDA said it found “serious violations” of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations during inspections at the Edo Sushi Express seafood processing facility on Sept.9 and 10 and 15, 2015. The company responded to FDA’s inspection report, but failed to document changes. The warning letter says fish or fish products from the plant, 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.”
Eco Sushi is in violations of current Good Manufacturing Practices (cGMP), adulteration and misbranding regulations. The cGMP gaps involve monitoring procedures, listing critical limits in the seafood processor’s HACCP, and maintaining sanitation control records. “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,” says the FDA warning letter.
The company’s “Spicy Tuna,” “Spicy Salmon,” “Spicy Shrimp,” and “Spicy Combo” products are adulterated, FDA says, because they contain the amino acid Phenylalanine, a food additive that has been deemed unsafe. “Spicy Shrimp” and “Spicy Tuna” sushi roll products are misbranded, the agency says, because eggs are not listed as a major food allergen. The company also does not use the appropriate format for listing nutritional information on its products, although it might be exempt if its production is less than 100,000 units a year, sold in the United States, or it employed fewer than 100 full time employees a year.
After explaining its detailed concerns, FDA also offered such comments as:
- 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.
FDA gave Eco Sushi 15 days to respond to the agency’s concerns.
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