P.T. Bonecom aka Bone Commercial Company – FDA Warning Letter, May 16, 2011

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