Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm590648.htm
Timestamp: 2019-01-18 18:19:26
Document Index: 697547380

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

KBF INC 8/16/17
CMS # 161266
Mr. MD Tafazzal Chowdhury, CEO
KBF Inc.
Astoria, NY 11106-4403
Dear Mr. Chowdhury:
On April 3rd and 4th, 2017, the U.S. Food and Drug Administration (FDA) inspected your seafood importer establishment, KBF Inc. located at 3621 22nd Street, Astoria, NY. 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 Kaski dried fish, Faisha Chapa dried fish, and Puthi Chapa dried 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 Kaski dried fish, Faisha Chapa dried fish, and Puthi Chapa dried fish manufactured by (b)(4).
On March 21, 2017, FDA collected a sample of Faisha Chapa dried fish manufactured by (b)(4) that you offered for import under entry number KM6-3502507-5. Your Faisha Chapa dried fish were adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act) in that FDA laboratory analysis found these products to be uneviscerated and to measure greater than five inches in length. FDA considers uneviscerated fish that are salt-cured, dried, or smoked and that are greater than five inches in length to represent a potentially life-threatening health hazard. On May 2, 2017, the Faisha Chapa dried fish manufactured by (b)(4), imported under entry number KM6-3502507-5, were voluntarily destroyed by you under FDA supervision. A copy of the FDA guidance, CPG Sec. 540.650, Uneviscerated Fish Products that are Salt-cured, Dried, or Smoked (Revised), is attached for your reference. The guidance can also be found on the FDA website at www.fda.gov.
On May 31, 2017, we received your response letter to the FDA 483, Inspectional Observations, issued to you on April 4, 2017. Your response is not adequate because it did not list the specific affirmative step you are performing nor did it include documentation of your performance of an affirmative step.
Please send your reply to the Food and Drug Administration, 158-15 Liberty Ave., Jamaica, NY 11433, Attention: Joseph Sullivan, Compliance Officer. If you have questions regarding any issues in this letter, please contact Joseph Sullivan at 718-662-5703.