FDA WARNING_LETTER - Citra Mina Seafood Corporation - June 10, 2008

On October 8, 2008, the FDA issued a Warning Letter to Citra Mina Seafood Corporation following an inspection of a U.S. importer, King Tuna, Inc. dba Gj Fresh LLC, in June 2008. The inspection revealed that King Tuna, Inc. was importing Yellowfin Tuna from Citra Mina Seafood Corporation. The FDA collected Citra Mina's HACCP plan for "Frozen Smoke Treated Species (Yellowfin and Bigeye, Marlin & Mahi Mahi)," which are intended for raw consumption or further cooking.

The FDA found serious deviations from the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123. Specifically, the HACCP plan was deemed inadequate because it did not list pathogen growth and toxin formation as a reasonably likely food safety hazard for raw product intended for raw consumption, violating 21 CFR 123.6(a) and (c)(1). Additionally, the plan lacked adequate monitoring procedures for histamine control at the receiving critical control point, as required by 21 CFR 123.6(c)(4). Checking only for adequate icing was insufficient; the FDA recommended reviewing boat records for on-board handling practices. The FDA also noted that the firm's hazard analysis for smoke treatment steps might be incomplete regarding time and temperature abuse and histamine development.

These violations render Citra Mina's smoke-treated fish products adulterated under