FDA WARNING_LETTER - EE HUI FOOD MANUFACTURE PTE LTD - June 25, 2019

On June 24-25, 2019, the FDA inspected EE HUI Food Manufacture PTE LTD in Singapore, identifying serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's frozen, ready-to-eat vacuum-packed surimi-based products are deemed adulterated under 21 U.S.C. § 342(a)(4).

The firm's July 15, 2019, response, including a revised HACCP plan, was inadequate. Key deficiencies include: 1. **Incomplete Hazard Analysis:** The HACCP plan, "Cooking & Frying Products," failed to list *Clostridium botulinum* growth and toxin formation (due to anaerobic conditions in vacuum packaging) and undeclared allergens (fish, crustacean shellfish, wheat, egg, dairy, soy) as reasonably likely food safety hazards, violating 21 CFR 123.6(a) and (c)(1). 2. **Missing Critical Control Points (CCPs):** The plan lacked CCPs for cooling after cooking and frying to control pathogenic bacteria growth and toxin formation from post-processing contamination, violating 21 CFR 123.6(c)(2). 3. **Inadequate Critical Limits:** * The critical limit for cooking/frying