Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm583434.htm
Timestamp: 2019-01-22 11:36:16
Document Index: 454146019

Matched Legal Cases: ['art 123', 'art 123', 'art 123', 'art 123', 'art 123', '§ 342', 'art 123', '§ 342']

Threeline Imports, Inc. 8/18/17
CMS # 532723
Ms. Malvina Kerzhner, President
Threeline Imports, Inc. 14A 53rd St
Brooklyn, NY 11232-2631 US
Dear Ms. Malvina Kerzhner:
On April 19th through April 24th, 2017, the U.S. Food and Drug Administration (FDA) inspected your seafood importer establishment located at 14A 53rd St, Brooklyn, NY 11232-2631 US. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). The specific requirements for imported fish and fishery products are set out in 21 CFR 123.12. As an importer of fish or fishery products, you must operate in accordance with the requirements of Part 123. In accordance with 21 CFR 123.12(d), 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, your ready-to-eat smoked sprats in oil, smoked sprats in tomato sauce, along with roasted sprats in tomato sauce intended to be distributed at ambient temperature 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. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
However, your firm did not perform an affirmative step for the following ready to eat fishery products which are packaged in glass jars, distributed at ambient temperatures, and manufactured by (b)(4) in (b)(4): smoked sprats in oil, smoked sprats in tomato sauce, and roasted sprats in tomato sauce. Your firm also did not perform an affirmative step for your imported ready-to-eat smoked sprats in oil which are packaged in metal cans, distributed at ambient temperatures, and manufactured by (b)(4) in (b)(4).