FDA WARNING_LETTER - PT. Winson Prima Sejahtera - April 09, 2023

On April 2-9, 2023, the FDA conducted a Foreign Remote Regulatory Assessment (FRRA) of Mr. Albert Winson's seafood processing facility in Indonesia, identifying serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's wild, frozen, vacuum-packaged, ready-to-eat yellowfin tuna is deemed adulterated under 21 U.S.C. § 342(a)(4) due to preparation, packing, or holding conditions that may render it injurious to health.

Key violations include: 1. **Inadequate Hazard Analysis:** The HACCP plan fails to list pathogen growth (e.g., Salmonella) as a reasonably likely food safety hazard for ready-to-eat raw tuna products, particularly concerning cumulative time exposures exceeding 2 hours at uncontrolled ambient temperatures above 21.1°C (70°F). 2. **Insufficient Critical Limits:** The HACCP plan's critical limit at a critical control point for histamine formation is inadequate, lacking necessary safety assurance. FDA recommends including ambient temperature limits. 3. **Failure to Implement Monitoring Procedures:** The firm is not consistently implementing monitoring procedures or maintaining records for scombrotoxin (histamine) formation at the receiving critical control point. Records show missing internal temperatures for multiple product lots. 4. **Inappropriate Correct