Diamond Head Seafood Wholesale, Inc. – FDA Warning Letter, Jun 13, 2012

On August 8, 2012, the FDA issued a Warning Letter to Diamond Head Seafood Wholesale, Inc. following an inspection from June 5-13, 2012. 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, the firm's histamine-forming fish, including chilled mahi mahi, escolar, marlin, and refrigerated, raw, ready-to-eat tuna, were deemed adulterated.

Key violations included: 1. **Inadequate Hazard Analysis:** The HACCP plan for "Fresh Fish" failed to list pathogen growth and toxin formation (due to time/temperature abuse for raw consumption fish) and allergens (finfish) as reasonably likely food safety hazards. 2. **Missing Critical Control Points (CCPs):** The HACCP plan did not identify Processing at the Cutting Room and Poke Room as CCPs to control histamine formation and pathogen growth/toxin formation in refrigerated, raw, ready-to-eat tuna. Temperature data logger records showed these rooms frequently exceeded 40°F for extended periods. 3. **Insufficient Critical Limits:** The HACCP plan's critical limit for cold storage was inadequate to control histamine formation and pathogen growth/toxin formation, with FDA recommending 40°F or below.