Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/shah-poran-distributors-inc-08122015
Timestamp: 2019-09-19 00:42:40
Document Index: 390236465

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

Shah Poran Distributors Inc - 08/12/2015 | FDA
Shah Poran Distributors Inc - 08/12/2015
Shah Poran Distributors Inc August 12, 2015
WARNING LETTER NYK-2015-47
Mr. Mohammad Talukder, Managing Director
5609/11 56th Drive
Maspeth, NY 11378-1123
Dear Mr. Talukder:
On June 24, 2015, the U.S. Food and Drug Administration (FDA) inspected your seafood importer establishment, located at 5609/11 56th Drive, Maspeth, NY 11378-1123. 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 frozen Shad, Hilsa (Tenualosa ilisha) fish 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 theymay 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 perform an affirmative step for your frozen Shad, Hilsa (Tenualosa ilisha) fish manufactured by (b)(4) and distributed by (b)(4), both located in (b)(4).