FDA WARNING_LETTER - PT. Primo Indo Ikan - January 22, 2019

The FDA inspected PT. Primo Indo Ikan's seafood processing facility in Bali, Indonesia, on January 21-22, 2019, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). The firm's frozen, vacuum-packed tuna products are considered adulterated.

Key violations include: 1. **Inadequate Hazard Analysis (21 CFR 123.6(a) and (c)(1)):** The HACCP plan, "Frozen Tuna Fish" (Jan 23, 2019), failed to list pathogen growth and toxin formation, including *Clostridium botulinum (C. botulinum)*, as reasonably likely hazards. This is critical for products consumed raw and those treated with carbon monoxide (CO) and vacuum-packed, which create anaerobic conditions conducive to *C. botulinum* growth. The plan also lacked a critical control point for CO treatment and proper labeling for vacuum-packed products regarding handling instructions. 2. **Missing Critical Control Points (21 CFR 123.6(c)(2)):** The HACCP plan did not list critical control points to control histamine formation, which can occur from inadequate time/temperature controls during various processing steps (e.g., washing, cutting, gassing, chilling). 3. **Inadequate Critical Limits (2