FDA WARNING_LETTER - Pt Tritos Sejahtera - October 25, 2017

On October 12-25, 2017, an FDA inspection of Gourmet Fusion Foods Inc., a U.S. seafood importer, revealed that PT. Tritos Sejahtera, an Indonesian processing facility, was supplying fish and fishery products. A review of PT. Tritos Sejahtera's "Frozen Tuna" HACCP plan, dated March 11, 2017, showed serious deviations from the seafood HACCP regulation (21 CFR Part 123), rendering their frozen vacuum-packaged tuna adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Significant deviations include: 1. **Inadequate Hazard Analysis and Critical Control Points (CCPs):** The HACCP plan failed to list CCPs for controlling scombrotoxin (histamine) formation during unrefrigerated processing (21 CFR 123.6(a) and (c)(2)). Additionally, for saku tuna, considered a raw Ready-to-Eat (RTE) product, the plan did not identify pathogen growth as a reasonably likely hazard. 2. **Inadequate Critical Limits:** Critical limits at specific CCPs were insufficient to control *Clostridium botulinum* toxin formation and scombrotoxin (histamine) formation (21 CFR 123.6(c)(3)). For refrigerated storage under reduced oxygen, the plan lacked adequate