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

Source: https://www.keypedia.com/records/warning_letter/pt-shimasse-prata-citra/d15b1c79-0ddb-4629-b92f-c89a8ee64802

> FDA WARNING_LETTER for PT Shimasse Prata Citra on October 25, 2017. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: PT Shimasse Prata Citra
- 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 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.
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## Related Officers

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

Company: https://www.keypedia.com/companies/pt-shimasse-prata-citra/aa87d710-f106-4b16-922f-056ddc58a3d0

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