FDA WARNING_LETTER - PT. Intimas Surya - May 25, 2011

On May 24-25, 2011, the FDA inspected PT. Intimas Surya's seafood processing facility in Jakarta, Indonesia, revealing serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The inspection resulted in an FDA-483, and subsequent responses from the firm on June 7 and September 7, 2011, were deemed inadequate.

The FDA determined that the firm's Snapper, Grouper, and Tuna products are adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, having been prepared, packed, or held under insanitary conditions. The firm acts as both a primary and secondary processor, making it responsible for controlling scombrotoxin (histamine) formation at receiving.

Specific violations include: 1. **Inadequate Hazard Analysis (21 CFR 123.6(a) and (c)(1)):** HACCP plans for Fresh Snapper and Grouper Fillet/Whole did not list Ciguatera Fish Poisoning (CFP) or Environmental Chemicals as reasonably likely hazards, despite government testing programs indicating their potential. 2. **Missing Critical Control Point (21 CFR 123.6(a) and (c)(2)):** HACCP plans for Fresh Tuna Loin Product and Fresh Tuna HG