FDA WARNING_LETTER - Vaughan Foods Inc. (Allison's Gourmet Kitchen) - August 04, 2011

The FDA inspected Vaughan Foods, Inc., dba Allison's Gourmet Kitchens, a seafood processing facility, from July 26 to August 4, 2011, and found serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). The firm's tuna salad and seafood salad products were deemed adulterated due to insanitary conditions.

Key violations included: 1. **Inadequate HACCP Plans:** The HACCP plans for tuna salad and seafood salad lacked adequate critical limits for controlling pathogen growth, *Clostridium botulinum* growth, and histamine formation. The critical control point "Mixed Process Area Temperature" monitored room temperature, which was insufficient for large product totes where internal temperatures reached 70°F or higher and product was held for extended periods. The firm's proposed corrective action to monitor internal product temperature was noted, but the revised HACCP plan was not provided for evaluation. 2. **Inappropriate Corrective Actions:** Corrective actions in the HACCP plans for Receiving Storage, Mixed Process Area Temperature, and Finished Goods Cooler CCPs were inadequate. They did not ensure the cause of deviations was corrected or address the duration product was held above 40°F. 3. **Insufficient Sanitation Monitoring:** The firm failed to monitor sanitation conditions sufficiently. Condensation was observed dripping