Sunic’s Food Inc, doing business as Sun Food Trading Company in Seattle, received an Aug. 4 warning letter from the U.S. Food and Drug Administration (FDA) about “serious violations” of federal laws and regulations for imported fish.
FDA said, “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 under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), and will be denied entry.
“Because our inspection identified serious violations for 21 CFR Part 123,” FDA added, “your frozen fish balls and fried fish cakes are adulterated under Section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4), in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. “
FDA said Sun Food Trading Company’s frozen fish balls and fried fish cakes, imported from an un-named country, lacked “an affirmative step for importation.” Such a step is required to ensure that FDA’s seafood regulations are followed.
“We may take further action if you do not promptly correct this violation, the FDA warning letter said. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act, 21 U.S.C. § 381(a), including placing them on ‘detention without physical examination,’ seize your product(s) and/or enjoin your firm from further violating the Act.”
Sun Food Trading Company was given 15 working days to respond to FDA’s allegations.
“Your response should outline the specific things you are doing to correct these violations,” the agency said. “You should include in your response documentation, such as HACCP and importer verification records and records that document the performance and results of your firm’s affirmative steps, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.”
