FDA WARNING_LETTER - PT Sukses Sejati - October 25, 2017

On October 12-25, 2017, an FDA inspection of Gourmet Fusion Foods Inc., a U.S. seafood importer, revealed they were importing fish and fishery products from PT. Sukses Sejati. Review of PT. Sukses Sejati's "Frozen Tuna" HACCP plan, dated April 10, 2017, showed serious deviations from 21 CFR Part 123, rendering their frozen vacuum-packaged tuna adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations 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. Additionally, for saku tuna, a raw Ready-to-Eat (RTE) product, the plan did not identify pathogen growth as a reasonably likely hazard, as required by 21 CFR 123.6(a) and (c)(2). 2. **Inadequate Critical Limits:** The plan's critical limits at specific CCPs were insufficient to control *Clostridium botulinum* toxin formation and scombrotoxin (histamine) formation. For refrigerated storage, a temperature of 38°F (3.3°C) or below with continuous monitoring, or continuous icing,