Sushi On a Roll, Inc – FDA Warning Letter, Aug 27, 2009

On December 16, 2009, the FDA issued a Warning Letter to Sushi On A Roll, Inc. following an August 27, 2009 inspection. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110).

The firm's sushi rolls containing fishery products were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Key violations included: 1. **Insufficient Sanitation Monitoring (21 CFR 123.11(b))**: * Lack of back-flow prevention device on a kitchen hose (water safety). * No detectable sanitizer in the sanitization compartment of the three-compartment dishwashing sink (handwashing/toilet facilities). * Milk crates with plates stored directly on the floor and unprotected glass light tubes over a processing table (protection from adulteration). * Unlabeled chemical containers, non-food grade lubricant, fabric protector, and automobile polish in the kitchen (labeling/storage of toxic chemicals). * Bird feces on a door and ants in the dry storage room (pest exclusion). 2. **Lack of