FDA WARNING_LETTER - Transbuana International Express - 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. Transbuana Internasional Express. Review of PT. Transbuana Internasional Express's "Frozen Tuna" HACCP plan, dated April 20, 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 fails to list CCPs for controlling scombrotoxin (histamine) formation during unrefrigerated processing. For raw Ready-to-Eat (RTE) tuna consumed as sushi, the plan also fails to identify pathogen growth as a reasonably likely hazard. (21 CFR 123.6(a) and (c)(2)) 2. **Inadequate Critical Limits:** * At the (b)(4) CCP, critical limits are insufficient to control *Clostridium botulinum* toxin formation for refrigerated storage/processing under reduced oxygen or product stored under ice. (21 CFR 123.6(c)(3)) * At the (b