FDA WARNING_LETTER - Fuji Food Products, Inc. - December 04, 2019

The FDA inspected Fuji Food Products, Inc.'s ready-to-eat (RTE) seafood facility in Brockton, MA, from November 12 to December 4, 2019. The inspection revealed the presence of *Listeria monocytogenes* (L. monocytogenes) and serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). FDA analyses confirmed 32 environmental swabs positive for L. monocytogenes, including 10 from food-contact surfaces. Whole genome sequencing indicated a resident strain since April 2019, demonstrating inadequate sanitation.

Violations included insufficient monitoring of food-contact surface cleanliness (worn conveyor belts, cracks in plastic belts), inadequate prevention of cross-contamination (overspray during cleaning, unsanitary sprayer placement), and failure to protect food from condensate (dripping onto processing areas). HACCP plan deficiencies included inadequate critical limits for pathogenic bacteria growth during refrigerated seafood transit and for undeclared major food allergens on labels.

The company initiated a voluntary recall, ceased operations, and engaged consultants for corrective actions, including deep cleaning, sanitation enhancement, facility repairs, and employee training. They proposed shifting the Brockton facility to a food storage warehouse. The FDA acknowledged these actions but expressed ongoing concerns about the resident L. monocytogenes strain and potential future food production. The company must provide documentation of updated programs, procedures, and records demonstrating implementation