Nobuo T. Hawaii Inc. – FDA Warning Letter, Sep 28, 2013

On January 3, 2014, the FDA issued a Warning Letter to Nobuo T. Hawaii Incorporated following an inspection from September 23-28, 2013, at their seafood processing facility in Honolulu, Hawaii. 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 (CGMP) regulation for foods (21 CFR Part 110).

The FDA determined that the firm's refrigerated histamine-forming fish, including fresh raw ready-to-eat Ahi tuna, were 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. **Inadequate HACCP Critical Limits:** The HACCP plan for refrigerated histamine-forming fish lacked adequate critical limits at Receiving and Cold Storage CCPs to control pathogenic bacteria growth and toxin formation due to time and temperature abuse. 2. **Insufficient Monitoring Procedures:** The HACCP plan's monitoring procedures at the Packing/Wrapping/Labeling CCP were inadequate to control allergen hazards. 3. **Inappropriate Corrective Actions:** The corrective action plan for histamine control at Receiving and Cold Storage CCPs was inappropriate, specifying cumulative time limits for temperature deviations that exceeded recommended guidelines. 4.