FDA WARNING_LETTER - P.T. Super Saku Bali - March 30, 2012

On March 29-30, 2012, the FDA inspected P.T. Super Saku Bali's seafood processing facility in Indonesia, identifying serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). The inspection resulted in an FDA-483, and despite the firm's April 24, 2012, response with corrective actions and revised HACCP plans for tuna, concerns remain.

The FDA determined that the firm's various forms of tuna are adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under conditions that may render them injurious to health.

Significant deviations include: 1. **Inadequate HACCP plans (21 CFR 123.6(c)(4)):** * Monitoring procedures for histamine control at receiving and processing critical control points are insufficient to ensure proper temperatures throughout storage. * Plans lack adequate monitoring controls to ensure proper handling instructions (keep frozen, thaw under refrigeration) are on labels to control *Clostridium botulinum* growth. 2. **Inappropriate predetermined corrective action plans (21 CFR 123.7(b)):** * Plans for histamine control do not specify how to prevent distribution or dispose of potentially adulterated products