FDA WARNING_LETTER - KJPL Restaurants Inc. - November 12, 2010

On February 4, 2011, the FDA issued a Warning Letter to KJPL Restaurants Inc. dba Hurricanes Soup & Chowder Co. following an inspection from October 27 to November 12, 2010. 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 regulation (21 CFR Part 110).

The firm's Lobster Bisque was deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as it was prepared, packed, or held under insanitary conditions.

Key violations included: * **Inadequate HACCP Plan:** The HACCP plan for "Soup with Fish & Shellfish & Mollusks" failed to list *Clostridium botulinum* as a reasonably likely food safety hazard, particularly concerning the packaging materials and the (b)(4) process. The critical limits for the heat/cook critical control point were insufficient. * **Lack of Continuous Monitoring:** The firm did not use equipment capable of continuously monitoring and recording the cook cycle, nor a continuous hot filling system. * **Insufficient Chilling Controls:** The HACCP plan lacked adequate controls at the chilling critical control point, specifically target temperatures and times for cooling. * **No Finished Product Storage Control:** An adequate