FDA WARNING_LETTER - Sugiyo USA Inc. - March 13, 2020

The FDA inspected a seafood processing facility in Anacortes, Washington, from February 26 to March 13, 2020. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the presence of *Listeria monocytogenes* (*L. monocytogenes*), a human pathogen, in the facility. As a result, the firm's ready-to-eat (RTE) surimi-based seafood analog products are deemed adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Nine out of 143 environmental swabs tested positive for *L. monocytogenes*, with seven from food-contact surfaces. Whole genome sequencing (WGS) indicated these isolates were highly related. The firm's own environmental testing also identified *Listeria* species in 13 post-cook locations between December 2019 and February 2020, without adequate documented corrective actions.

Violations of sanitation monitoring (21 CFR 123.11(b)) included: water dripping onto RTE products from an IQF freezer, use of high-pressure hoses causing aerosolized water in RTE processing areas, peeling paint and mold/mildew on walls, heavily soiled conveyor belts, improperly stored hose nozzles, and soiled insulated water lines. Additionally, sanit