FDA WARNING_LETTER - Kyokuyo Global Seafoods Co. LTD. - January 22, 2024

The FDA inspected Kyokuyo Global Seafoods Co. LTD. in Thailand from January 19-22, 2024, finding serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's ready-to-eat raw and cooked mackerel and frozen red shrimp products are deemed adulterated under 21 U.S.C. § 342(a)(4).

Key violations include: 1. Failure to list *Staphylococcus aureus* growth and toxin formation as a reasonably likely food safety hazard in HACCP plans for frozen mackerel products, despite processing at ambient temperatures. 2. Failure to list a critical control point (CCP) for overnight refrigerated thawing of RTE frozen mackerel to control histamine formation and pathogen growth, and for *Clostridium botulinum* in vacuum-sealed products. 3. Inappropriate corrective action plans for allergen hazards at packing and labeling steps, failing to cover potentially affected products or address the cause of deviation.

The firm's February 8, 2024, response was deemed inadequate. Kyokuyo Global Seafoods must respond within 15 working days with specific corrective actions, including revised HACCP plans and five consecutive days of monitoring records. Failure to comply may result in refusal of admission for imported products, including detention without physical examination (DWPE) under Import Alert 16-