PT Anugerah Lestari Abadi – FDA Warning Letter, Oct 25, 2017

On October 12-25, 2017, an FDA inspection of Gourmet Fusion Foods Inc., a U.S. seafood importer, revealed that PT Anugerah Lestari Abadi was supplying fish and fishery products. A review of PT Anugerah Lestari Abadi's "Frozen Tuna" HACCP plan, dated March 28, 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 included: 1. Failure to list critical control points for controlling scombrotoxin (histamine) formation during unrefrigerated processing, as required by 21 CFR 123.6(a) and (c)(2). Additionally, for raw Ready-to-Eat (RTE) tuna saku, the plan did not identify pathogen growth as a reasonably likely hazard. 2. Inadequate critical limits at critical control points, violating 21 CFR 123.6(c)(3). Specifically, critical limits for Clostridium botulinum toxin formation at the "(b)(4)" critical control point were insufficient, and critical limits for scombrotoxin (histamine) formation during transit from supplier to plant at the "(b)(4)" critical control point were also inadequate. 3