FDA WARNING_LETTER - PT. Nusantara Jaya Abadi - 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 products from PT. Nusantara Jaya Abadi. Review of PT. Nusantara Jaya Abadi's "Frozen Tuna" HACCP plan, dated February 18, 2016, 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, specifically regarding cumulative time and temperature exposure. Additionally, for frozen tuna consumed as sushi (raw Ready-to-Eat), the plan did not identify pathogen growth as a reasonably likely hazard, violating 21 CFR 123.6(a) and (c)(2). 2. **Inadequate Critical Limits:** The plan's critical limits at the "(b)(4)" CCP were insufficient to control *Clostridium botulinum* toxin formation and scombrotoxin (histamine) formation during transit from supplier to plant, violating 21 CFR 123.6(c)(3). FDA recommended specific