FDA WARNING_LETTER - New 88 Japanese Food Trading Inc - September 06, 2019

The FDA inspected New 88 Japanese Food Trading Inc. in Flushing, NY, from August 13 to September 6, 2019. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123) and the presence of *Listeria monocytogenes* (L. monocytogenes) in the facility.

FDA laboratory analyses of environmental swabs found 10 out of 80 swabs positive for *L. monocytogenes*, including three from food-contact surfaces (table edge, swinging door rubber strips, cutting board). Whole genome sequencing identified two distinct *L. monocytogenes* strains, one found across multiple zones, indicating cross-contamination. These findings indicate inadequate control of *L. monocytogenes*.

The company's ready-to-eat (RTE) tuna loins and imported refrigerated tuna were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Significant deviations from seafood HACCP regulations included: 1. Failure to sufficiently monitor sanitation conditions and practices, specifically regarding equipment cleanability (grooved cutting board), minimizing food contamination (condensation dripping onto tuna, splashing detergent/water onto ice/fish, pest issues), and protecting finished food from contamination. 2. Failure to maintain required sanitation monitoring records for RTE tuna loins. 3. Inadequate