FDA WARNING_LETTER - PT Shimasse Prata Citra - October 25, 2017

On October 12-25, 2017, an FDA inspection of Gourmet Fusion Foods Inc., a U.S. seafood importer, revealed that they were importing fish and fishery products from PT Shimasse Prata Citra. A review of PT Shimasse Prata Citra's "Frozen Tuna" HACCP plan, dated March 24, 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. For frozen tuna saku, considered a raw Ready-to-Eat (RTE) product, the plan also failed to identify pathogen growth as a reasonably likely hazard. 2. **Inadequate Critical Limits:** * At a specific CCP, critical limits were insufficient to control *Clostridium botulinum* toxin formation for refrigerated storage/processing under reduced oxygen or product stored under ice. * At another CCP, critical limits were inadequate to control scombrotoxin (histamine) formation during transit from supplier to processing plant, as internal temperature measurements alone were deemed insufficient. 3