# FDA WARNING_LETTER - PT. Tuna Permata Rezeki - October 22, 2010

Source: https://www.globalkeysolutions.net/records/warning_letter/pt-tuna-permata-rezeki/b6a2552e-14e1-41d8-81a6-e3b9ef166785

> FDA WARNING_LETTER for PT. Tuna Permata Rezeki on October 22, 2010. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: PT. Tuna Permata Rezeki
- Inspection Date: 2010-10-22
- Product Type: Food
- Office Name: Department of Health and Human Services
- Summary: On March 9, 2011, the FDA issued a Warning Letter to PT. Tuna Permata Rezeki following an inspection on October 21-22, 2010, which revealed deviations from the Seafood Hazard Analysis and Critical Control Point (HACCP) Regulation (21 CFR Part 123). The inspection resulted in an FDA-483, and the firm's November 6, 2010 response, including a revised HACCP plan, was acknowledged.

The FDA determined the firm's tuna was adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, having been prepared, packed, or held under insanitary conditions. Serious deviations included:

1.  **Inadequate Hazard Analysis (21 CFR 123.6(a) and (c)(1)):** The revised HACCP plan for "Processing Of Frozen Tuna" did not list *Clostridium botulinum* growth and toxin formation as a hazard during the "Processing (Filleting, Skinning, Trimming, Cutting, Refrigeration and Packaging)" critical control point, despite products being held in sealed bags for extended periods.
2.  **Missing Critical Limits (21 CFR 123.6(c)(3)):** The revised HACCP plan lacked a critical limit for "Decomposition" at the "Receiving raw material" critical

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/pt-tuna-permata-rezeki/88f11bd7-2ae7-438b-9125-154842f3e6ae

Office: https://www.globalkeysolutions.net/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861