FDA WARNING_LETTER - Sakhon Wattana Thang Chue Hah - February 14, 2024

On June 25, 2024, the FDA issued a Warning Letter to Sakhon Wattana (Thang Chue Hah) following an inspection on February 13-14, 2024. The inspection revealed serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) for their ready-to-eat fish sauce made from fermented, salted, uneviscerated anchovies, rendering the product adulterated.

Key violations include: 1. **Inadequate Hazard Analysis:** The HACCP plan failed to list *Clostridium botulinum* and toxin formation, and *Staphylococcus aureus* growth and toxin formation as reasonably likely food safety hazards. 2. **Inadequate Critical Limits:** The HACCP plan's critical limits for histamine control at the pre-fermentation step were insufficient. Specifically, it lacked a minimum water activity (Aw) or water phase salt (WPS) for the salted fish, and the listed temperature critical limits were inadequate and lacked clarity (internal vs. refrigeration). 3. **Inadequate Monitoring Procedures:** The HACCP plan did not list monitoring procedures for temperature critical limits, and the single temperature reading on the receiving record was deemed insufficient. 4. **Inadequate Corrective Actions:** Corrective actions for raw materials and fish sauce storage were not appropriate to ensure affected product did not enter commerce