FDA WARNING_LETTER - Pt. Indomaguro Tunas Unggul - October 19, 2010

The FDA inspected Pt. Indomaguro Tunas Unggul's seafood processing facility in Jakarta, Indonesia, on October 18-19, 2010, and found 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 5, 2010, response, including a revised HACCP plan, was acknowledged.

The FDA determined the firm's tuna is adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions. Serious deviations include: 1. **Inadequate HACCP Plan:** The revised HACCP plan for tuna lacks a critical control point for the holding period during processing to control histamine and *Clostridium botulinum* growth and toxin formation, despite a potential for time and temperature abuse during an extended refrigerated hold. 2. **Failure to Implement Monitoring Procedures:** The firm's HACCP plan lists continuous monitoring with a digital temperature and data logger for cooler storage, but the inspection revealed hourly visual monitoring, and records showed hourly checks, not continuous monitoring. 3. **Inappropriate Corrective Actions:** The corrective action plan for "Receiving Raw Material" and "Cooler Storage" critical control points is inadequate. Re-icing and checking individual fish for histamine after high