# FDA WARNING_LETTER - Pt Tritos Sejahtera - October 25, 2017

Source: https://www.keypedia.com/records/warning_letter/pt-tritos-sejahtera/5d4b1a3d-34ad-45f3-abaf-25cca3132a72

> FDA WARNING_LETTER for Pt Tritos Sejahtera on October 25, 2017. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Pt Tritos Sejahtera
- Inspection Date: 2017-10-25
- Product Type: Food
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: On October 12-25, 2017, an FDA inspection of Gourmet Fusion Foods Inc., a U.S. seafood importer, revealed that PT. Tritos Sejahtera, an Indonesian processing facility, was supplying fish and fishery products. A review of PT. Tritos Sejahtera's "Frozen Tuna" HACCP plan, dated March 11, 2017, showed serious deviations from the seafood HACCP regulation (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.  **Inadequate Hazard Analysis and Critical Control Points (CCPs):** The HACCP plan failed to list CCPs for controlling scombrotoxin (histamine) formation during unrefrigerated processing (21 CFR 123.6(a) and (c)(2)). Additionally, for saku tuna, considered a raw Ready-to-Eat (RTE) product, the plan did not identify pathogen growth as a reasonably likely hazard.
2.  **Inadequate Critical Limits:** Critical limits at specific CCPs were insufficient to control *Clostridium botulinum* toxin formation and scombrotoxin (histamine) formation (21 CFR 123.6(c)(3)). For refrigerated storage under reduced oxygen, the plan lacked adequate

## Related Officers

- [Director](https://www.keypedia.com/people/william-a-correll/f9e634a2-8e56-4c9b-984c-304f0c7db122)

Company: https://www.keypedia.com/companies/pt-tritos-sejahtera/7b03827d-0c6b-42e5-b49d-4a522b339311

Office: https://www.keypedia.com/offices/center-for-food-safety-and-applied-nutrition/e04dc4e5-ee4f-4b0d-be8c-1139531ddab2