FDA WARNING_LETTER - Concept Asia Food Service LLC - January 26, 2012

On January 10-26, 2012, the FDA inspected Concept Asia Food Service, LLC's seafood processing facility in Seattle, Washington, and found serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). These violations render their sushi roll products, including salmon, eel, tai, imitation crab, and tuna rolls, adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate HACCP Plan Critical Limits:** The HACCP plan for sushi rolls lists an insufficient pH critical limit for sushi rice to control *Bacillus cereus* and *Staphylococcus aureus*, as the stated pH is not low enough to inhibit their growth. 2. **Missing Critical Control Points:** The HACCP plans fail to list critical control points for: * Cooling after cooking for pathogenic bacteria growth in rice, with observed excessive cooling times. * Finished product storage for histamine formation in tuna/spicy tuna rolls. * Finished product storage for pathogenic bacteria growth in all sushi rolls. 3. **Inappropriate Corrective Actions:** Corrective action plans for sushi rice making are inadequate, lacking details on correcting the cause of deviation or product disposition,