FDA WARNING_LETTER - Advantage Foods, LLC - May 09, 2011

On September 6, 2011, the FDA issued a Warning Letter to Advantage Foods, LLC, following an inspection from April 26 to May 9, 2011. The inspection revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice regulations (21 CFR Part 110).

The FDA found that Advantage Foods' canned pasteurized crab meat, mahi-mahi, grouper, snapper, amberjack, stone crab claws, and fresh crab meat were adulterated because they were prepared, packed, or held under insanitary conditions.

Key violations included: 1. **Inadequate HACCP Plans:** The firm's HACCP plan for various fish (e.g., amberjack, mahi-mahi) had inadequate monitoring procedures and frequencies at receiving and storage Critical Control Points (CCPs) to control histamine formation and *Clostridium botulinum*. For instance, temperature monitoring at receiving was insufficient to ensure compliance with critical limits, and storage monitoring frequency was unclear. 2. **Failure to Implement Monitoring Procedures:** The firm did not follow its own HACCP plan's monitoring procedure for iced crabmeat storage, as pasteurized crabmeat was observed stored without ice. 3. **Lack of Affirmative Steps for Imported Products:** Advantage Foods failed to implement affirmative steps to ensure imported fish and fishery products