FDA WARNING_LETTER - KBF INC - April 04, 2017

On April 3-4, 2017, the FDA inspected KBF Inc., a seafood importer in Astoria, NY, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). As an importer, KBF Inc. must ensure imported fish and fishery products comply with 21 CFR Part 123.

The primary violation was the firm's failure to implement an affirmative step to ensure imported Kaski, Faisha Chapa, and Puthi Chapa dried fish were processed according to seafood HACCP regulations, as required by 21 CFR 123.12(a)(2)(ii).

Furthermore, a sample of Faisha Chapa dried fish, imported under entry KM6-3502507-5, was found to be uneviscerated and greater than five inches in length, posing a potentially life-threatening health hazard. This product was deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) and was voluntarily destroyed on May 2, 2017.

KBF Inc.'s May 31, 2017, response to the FDA 483 was inadequate as it did not specify the affirmative step being performed or provide supporting documentation. Failure to correct these violations may result in refusal of