FDA WARNING_LETTER - Monarch Seafoods, Inc. - June 14, 2012

On September 10, 2012, the FDA issued a Warning Letter to Monarch Seafoods, Inc. following an inspection from June 11-14, 2012, which revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The FDA determined that the company's fresh, refrigerated seafood products, including scombroid finfish 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.

The company's response to the FDA 483, received on June 29, 2012, was deemed inadequate. Significant violations included:

1. **Inadequate Hazard Analysis:** The HACCP plan for Tuna failed to list "pathogen growth and toxin formation as a result of time/temperature abuse for fish intended for raw consumption" and "undeclared allergens" as reasonably likely food safety hazards, violating 21 CFR 123.6(a) and (c)(1).

2. **Insufficient Critical Limit:** The HACCP plan's critical limit for histamine formation at the "Receiving" critical control point was inadequate. The FDA observed tuna received in non-refrigerated vehicles, requiring the plan to include both internal temperature monitoring and visual observation