True World Food Boston, LLC – FDA Warning Letter, Oct 27, 2010

On March 25, 2011, the FDA issued a Warning Letter to True World Food Boston, LLC, following an inspection from October 4-27, 2010. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). Consequently, their raw refrigerated fluke, Nigiri, and sushi products were deemed adulterated.

Key violations included: 1. **Inadequate Hazard Analysis:** The HACCP Plan #6 for raw refrigerated fluke failed to list parasites as a reasonably likely food safety hazard, a responsibility of the final processor. 2. **Inappropriate Corrective Actions:** The HACCP plan for Nigiri and sushi products listed "move product to another cooler" as a corrective action for pathogen and histamine/scombrotoxin control, despite the firm having only one cooler.

The FDA also provided additional comments: * The HACCP plan for "Nigiri and Sushi Rolls" needs a comprehensive hazard analysis and critical control points for all manufacturing steps (thawing, ingredient prep, assembly, rolling, cutting, packaging/labeling) to control pathogen growth and histamine. * Monitoring procedures at the "Receiving Finished Product Label" critical control point for "Food allergens/label accuracy" were inadequate, as they relied on Certificates of Compliance