Sushi USA Inc. – FDA Warning Letter, Mar 22, 2013

On April 19, 2013, the FDA issued a Warning Letter to Sushi USA, Inc., a ready-to-eat (RTE) sushi manufacturer, following an inspection from March 14-22, 2013. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their fish and fishery products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Lack of HACCP Plan:** The firm failed to conduct a hazard analysis and implement a written HACCP plan for various sushi products (tuna, mackerel, escolar, salmon, shrimp, eel, tilapia, California Roll) to control pathogen growth, toxin formation from time/temperature abuse, and undeclared allergens (21 CFR 123.6(a) and (b)). Additionally, there were inadequate controls for monitoring walk-in cooler temperatures and pH of cooked sushi rice. 2. **Insufficient Sanitation Monitoring:** The firm did not sufficiently monitor sanitation conditions (21 CFR 123.11(b)). Specific issues included: * **Food Contact Surfaces:** A chef used the same knives, cutting board, and gloves for seafood and non-seafood products without proper washing or sanitization between uses or before storage (