Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/harbor-seafood-inc-486585-01082016
Timestamp: 2019-06-27 08:24:17
Document Index: 68783784

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

Harbor Seafood Inc. - 486585 - 01/08/2016 | FDA
Harbor Seafood Inc. - 486585 - 01/08/2016
Harbor Seafood Inc. MARCS-CMS 486585 — 08/01/2016
New Hyde Park,, NY 11040-3008
WARNING LETTER NYK-2016-20
Mr. Peter Cardone, Chairman of the Board
Mr. Christain Limberg, President
Dear Mr. Cardone and Mr. Limberg:
We inspected your seafood importer establishment, located at 969 Lakeville Road, New Hyde Park, NY 11040-3008 on November 6, 2015. 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 a serious violation for 21 CFR Part 123, your frozen tuna steak individually vacuum packed, are adulterated under Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4)), in that it has been prepared, packed, or held under insanitary conditions whereby it 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.
You must implement an affirmative step which ensures that the fish and fishery product(s) you import are processed in accordance with the seafood HACCP Regulation, to comply with 21 CFR123.12(a)(2)(ii). However, your firm did not implement an affirmative step for frozen tuna steak individually vacuum packed, manufactured by (b)(4) located in (b)(4).
We acknowledge that your firm maintains copies of product specifications for the importation of the frozen tuna steaks, however these specifications fail to address the significant process related hazard of metal inclusion.
Ms. Kathleen Maurer, Import Manager
Mr. Stephen Thompson, Quality Control Director
Harbor Seafood Inc. - Close Out Letter 11/16/17