FDA WARNING_LETTER - pt Mitra T.N. - October 25, 2017

The FDA issued a Warning Letter to PT Mitra T.N. following an October 12-25, 2017 inspection of a U.S. importer, Gourmet Fusion Foods Inc., which imports seafood from PT Mitra T.N. The inspection revealed serious deviations in PT Mitra T.N.'s "Frozen Tuna" HACCP plan, dated March 28, 2016, from the requirements of 21 CFR Part 123, the seafood HACCP regulation. Consequently, the firm's frozen vacuum packaged tuna is considered adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key violations include: 1) Failure to conduct a proper hazard analysis and list critical control points for scombrotoxin formation and pathogen growth in raw Ready-to-Eat tuna, as required by 21 CFR 123.6(a) and (c)(2). 2) Failure to establish adequate critical limits in the HACCP plan for controlling Clostridium botulinum toxin formation and scombrotoxin formation during transit, violating 21 CFR 123.6(c)(3). 3) The corrective action plan for Clostridium botulinum toxin formation was deemed inappropriate, failing to ensure the cause of deviation is corrected and adulterated product does not enter commerce, contrary to 21 CFR 123.7(b). PT Mitra T.N. must respond within fifteen working days, outlining specific corrective steps, including a revised HACCP plan, five consecutive days of monitoring records, and a description of tuna suppliers. Failure to adequately respond may lead to further action, such as refusal of admission and detention without physical examination (DWPE) under Import Alert #16-120.