FDA WARNING_LETTER - Threeline Imports, Inc. - April 24, 2017

On April 19-24, 2017, the FDA inspected Threeline Imports, Inc. and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), specifically 21 CFR 123.12 for imported fish and fishery products. The firm failed to implement an affirmative step to ensure imported fish and fishery products are processed in accordance with the seafood HACCP Regulation, as required by 21 CFR 123.12(a)(2)(ii).

This violation pertained to several ready-to-eat products distributed at ambient temperatures: smoked sprats in oil, smoked sprats in tomato sauce, and roasted sprats in tomato sauce, packaged in glass jars and manufactured by (b)(4) in (b)(4). Additionally, the firm did not perform an affirmative step for imported ready-to-eat smoked sprats in oil, packaged in metal cans and manufactured by (b)(4) in (b)(4).

These products 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 FDA may refuse admission of these products under Section 801(a) of the Act,