FDA WARNING_LETTER - PT. GALAXY NUSA DUA - 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. Galaxy Nusa Dua. A review of PT. Galaxy Nusa Dua's "Frozen Tuna" HACCP plan, dated February 27, 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 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. FDA recommends monitoring cumulative time and temperature exposure. Additionally, for frozen tuna consumed as sushi (raw Ready-to-Eat), the plan should identify pathogen growth as a reasonably likely hazard. 2. **Inadequate Critical Limits:** Critical limits at the "(b)(4)" CCP were insufficient to control *Clostridium botulinum* toxin formation, with FDA recommending continuous monitoring at 38°F (3.3°C) or continuous icing for refrigerated/iced products. Critical limits at the "(b)(4)" CCP were also inadequate for controlling scombrotoxin formation during transit, as internal temperature measurements alone are insufficient. FDA