FDA WARNING_LETTER - DJ Tuna Express Inc. - September 01, 2011

On September 29, 2011, the FDA issued a Warning Letter to DJ Tuna Express, Inc. following an inspection from August 29 to September 1, 2011, at their Hialeah, FL seafood processing facility. 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 (21 CFR Part 110).

The FDA determined that the firm's ready-to-eat (RTE) fresh tuna, salmon, and cobia products 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. **Lack of HACCP Plan:** No HACCP plan for fresh cobia to control pathogenic bacteria growth and toxin formation. 2. **Inadequate Hazard Analysis:** The HACCP plan for fresh tuna did not list pathogenic bacteria growth and toxin formation as a food safety hazard. 3. **Missing Critical Control Points (CCPs):** The fresh salmon HACCP plan omitted storage as a CCP for pathogenic bacteria, and the fresh tuna HACCP plan omitted in-process storage as a CCP for Scombrotoxin and pathogenic bacteria. 4. **Failure to Implement Monitoring