Sushi Boy Inc – FDA Warning Letter, Dec 6, 2011

On March 13, 2012, the FDA issued a Warning Letter to Sushi Boy, Inc. following an inspection from November to December 2011, which revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). The FDA determined that Sushi Boy's ready-to-eat sushi products, including those with shrimp, tuna, and salmon, were adulterated due to insanitary conditions.

Key violations include: 1. **Inadequate Hazard Analysis:** The HACCP plan failed to list undeclared sulfiting agents for shrimp and histamine formation for tuna as food safety hazards. 2. **Missing Critical Control Points (CCPs):** The HACCP plan for raw salmon, raw tuna, and vacuum-packed fishery products did not include CCPs for "Receiving" and "Storage" to control pathogen growth in refrigerated salmon, and "Thawing" for pathogen growth and *Clostridium botulinum* toxin formation in various ready-to-eat and vacuum-packed products. 3. **Failure to Take Corrective Action:** The firm did not take appropriate corrective action when sushi rice pH deviated from the critical limit (e.g., pH 4.39 on 5/30/11 and 5/31/11, 4