FDA WARNING_LETTER - PT Sekar Subur 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 and fishery products from PT Sekar Subur Abadi. A review of PT Sekar Subur Abadi's "Frozen Tuna" HACCP plan, dated April 4, 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.

Significant deviations include: 1. Failure to list critical control points for scombrotoxin (histamine) formation during unrefrigerated processing, as required by 21 CFR 123.6(a) and (c)(2). The FDA recommends monitoring cumulative time and temperature exposure. Additionally, for saku tuna, a raw Ready-to-Eat product, pathogen growth should be identified as a reasonably likely hazard. 2. Inadequate critical limits for Clostridium botulinum toxin formation and scombrotoxin (histamine) formation, violating 21 CFR 123.6(c)(3). Specifically, critical limits for refrigerated storage/processing or iced storage were insufficient for Clostridium botulinum. For scombrotoxin, internal temperature measurements at delivery were inadequate; transportation records showing continuous temperature control or complete