FDA WARNING_LETTER - Interpage Co.

On July 16, 2015, the FDA inspected Interpage Co., Inc., a seafood importer in Brooklyn, NY, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). Specifically, the firm failed to implement an affirmative step to ensure imported canned ready-to-eat mackerel and roasted sprats in tomato sauce were processed in accordance with seafood HACCP regulations, as required by 21 CFR 123.12(a)(2)(ii).

The imported products, manufactured by (b)(4) in (b)(4), are considered adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)) because they were prepared, packed, or held under insanitary conditions. The firm's July 21, 2015, response was deemed inadequate as it did not provide sufficient assurance of compliance. There is no active Memorandum of Understanding (MOU) between the (b)(4) and the FDA covering fish or fishery products, and a letter from the Republic of (b)(4)'s Food and Veterinary Service did not adequately assure compliance with U.S. FDA seafood HACCP regulations.

Failure to correct these violations may lead to refusal of admission for imported products, detention without physical