Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/evelyn-effan-11102015
Timestamp: 2019-09-16 17:44:53
Document Index: 370171111

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

Evelyn Effan - 11/10/2015 | FDA
Evelyn Effan - 11/10/2015
Evelyn Effan November 10, 2015
Evelyn Effan
WARNING LETTER NYK-2016-8
Ms. Evelyn Effan, Sole Proprietor
1151 East 229th Street, Apt#5F
Bronx, NY 10466-5347
Dear Ms. Effan:
We inspected your seafood importer establishment, located at 1151 East 229th Street, Apt#5F on October 8, 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 serious violations for 21 CFR Part 123, your smoked fish herring and smoked akwabi 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 smoked fish herring and smoked akwabi manufactured by (b)(4) located in (b)(4).
On (b)(4), FDA collected a sample each of smoked fish herring and smoked akwabi manufactured by (b)(4) in (b)(4) that you offered for import under entry number (b)(4). Your smoked fish herring and smoked akwabi, entry number (b)(4), were adulterated within the meaning of section 402(a)(1) of the Act (21 U.S.C. § 342(a)(1) in that FDA laboratory analysis found all the fishery products to be uneviscerated.