# FDA WARNING_LETTER - P.T. Bonecom aka Bone Commercial Company - May 16, 2011

Source: https://www.globalkeysolutions.net/records/warning_letter/pt-bonecom-aka-bone-commercial-company/92da5555-5c27-42de-8638-73a552144fd2

> FDA WARNING_LETTER for P.T. Bonecom aka Bone Commercial Company on May 16, 2011. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: P.T. Bonecom aka Bone Commercial Company
- Inspection Date: 2011-05-16
- Product Type: Food
- Office Name: Department of Health and Human Services
- Summary: On September 14, 2011, the FDA issued a Warning Letter to P.T. Bonecom (Bone Commercial Company) following an inspection of their seafood processing facility in Jakarta, Indonesia, on May 15-16, 2011. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their frozen, vacuum-packaged fish products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

The FDA found the company's June 15, 2011, response to the FDA-483 inadequate. Key violations include:
1.  **Inadequate Hazard Analysis:** HACCP plans for frozen, vacuum-packaged fish failed to identify *Clostridium botulinum* as a food safety hazard, particularly at the "Chilling" critical control point for CO-treated tuna. Labels also lacked a required warning statement: "Important, keep frozen until used, thaw under refrigeration immediately before use." All HACCP plans also failed to identify undeclared allergens and include a labeling critical control point for proper market names.
2.  **Insufficient Critical Limits:** HACCP plans for "Frozen Tuna" and "Frozen Tuna CO Treatment" had inadequate critical limits at the "Receiving" critical control point for histamine control. The plans needed to specify monitoring

## Related Officers

- [Program Division Director](https://www.globalkeysolutions.net/people/michael-w-roosevelt/136906d6-8e93-4080-acf9-5d48d4509a80)

Company: https://www.globalkeysolutions.net/companies/pt-bonecom-aka-bone-commercial-company/333b6e94-ac4c-4e7f-8762-6d1ac9cb96bf

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