FDA WARNING_LETTER - Maruhachi Muramatsu Inc., Danchi Factory - April 24, 2024

On October 17, 2024, the FDA issued a Warning Letter to Maruhachi Muramatsu Inc., Danchi Factory, following an inspection on April 23-24, 2024. The inspection revealed serious violations of the seafood HACCP regulation (21 CFR 123) for their refrigerated reduced oxygen packaged (ROP) Noko Dashi Katsuo soup product, rendering it adulterated.

The firm's May 10, 2024, HACCP plan for Noko Dashi Katsuo was deemed inadequate. Specific deficiencies include: 1. **Inadequate Critical Limits:** * At the thermal processing CCP, the critical limit was insufficient to control vegetative pathogen survival. It lacked specific factors (e.g., flow rate, temperature, hold time) needed for a 6-log reduction of non-proteolytic *Clostridium botulinum* type B. * At the cooling CCP, the critical limit was inadequate to control spore-forming pathogen growth and toxin formation. It did not specify cooling from 57.2°C to 21.1°C within two hours and to 4.4°C within an additional four hours.

2. **Missing Critical Control Points (CCPs):** * The HACCP plan failed to list a CCP for the filling step to prevent recontamination with pathogens, including non-