FDA WARNING_LETTER - K-Fat Inc. - May 09, 2014

An FDA inspection of K-Fat Inc., a seafood importer in Brooklyn, NY, from May 7-9, 2014, revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123, particularly for imported fish and fishery products under 21 CFR 123.12. The primary violation was the firm's failure to implement an affirmative step to ensure imported vacuum-packed frozen anchovy products complied with the seafood HACCP regulation, as required by 21 CFR 123.12(a)(2)(ii). An FDA sample of this product was found to be decomposed and adulterated under Section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act, leading to its refusal of admission. The product was also deemed adulterated under Section 402(a)(4) due to insanitary conditions. The firm's written response to the FDA 483 was inadequate due to a lack of supporting documentation for promised corrective actions. K-Fat Inc. must respond within fifteen working days, detailing specific corrections with supporting documentation, including HACCP and importer verification records. Failure to correct these violations could result in further regulatory actions, such as refusal of admission, detention without physical examination, product seizure, injunction, and assessment of re-inspection fees.