Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/adriatic-seafood-inc-498699-06162016
Timestamp: 2019-09-23 14:15:48
Document Index: 475450446

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

Adriatic Seafood Inc - 498699 - 06/16/2016 | FDA
Adriatic Seafood Inc - 498699 - 06/16/2016
Adriatic Seafood Inc MARCS-CMS 498699 — June 16, 2016
WARNING LETTER NYK-2016-34
Mr. Safet Kovacevic, President/Part-Owner
Adriatic Seafood Inc.
Staten Island, NY 10305-1814
We inspected your seafood importer establishment, located at 129 Willow Avenue, Staten Island, NY 10305-1814 on April 22 through May 12, 2016. 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 Fresh Anchovies and Fresh Sardines, 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 affirmative steps for Fresh Anchovies, manufactured by (b)(4), located in (b)(4) or Fresh Sardines, manufactured by (b)(4) located in (b)(4).
Adriatic Seafood Inc - Close Out Letter 5/23/17