FDA WARNING_LETTER - Sushi Avenue, Inc. - August 18, 2011

On July 12-14, 19-20, and August 9, 11, 18, 2011, the FDA inspected Sushi Avenue, Inc.'s seafood processing facility. 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). As a result, several of the firm's products, including various sushi rolls and combos, were deemed adulterated under 21 U.S.C. § 342(a)(4) due to insanitary preparation, packing, or holding conditions.

Key violations included: 1. **Inadequate Hazard Analysis and HACCP Plans:** HACCP plans for "Wild Frozen Raw Tuna" and "Frozen Raw Yellowtail" failed to list pathogen growth as a food safety hazard. Additionally, plans for "Frozen Cooked Real Crab Meat," "Cooked Squid," "Frozen Cooked Tempura Shrimp," "Frozen Imitation Crab Meat," "Frozen Imitation Crab Stick," "Smoked Salmon," "Squid Salad," and "Frozen Raw Yellowtail" did not list pathogen growth at the Packaging Labeling critical control point. 2. **Failure to Implement Monitoring Procedures:** The firm did not follow monitoring procedures for product temperature at the Thawing critical control point and internal temperature of ready