FDA WARNING_LETTER - Kettle Cuisine, LLC - August 05, 2014

The FDA inspected Kettle Cuisine, LLC's seafood processing facility in Lynn, MA, from July 22 to August 5, 2014. The inspection revealed a serious violation of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their seafood products, including cooked, refrigerated lobster bisque and Manhattan clam chowder in reduced oxygen retail cups, adulterated.

The primary violation was the firm's HACCP plan for these products, dated May 7, 2014, which failed to list the food safety hazard of pathogenic bacteria introduction after cooking. An FDA investigator observed employees reintroducing underweight or defective finished Manhattan clam chowder into the holding tank during filling, without further cooking. While the firm stated they would cease this practice, their response was deemed inadequate as it did not address the failure to identify pathogenic bacteria introduction as a hazard at the hot filling, container sealing, and container cooling steps.

The FDA cited 21 CFR 123.6(a) and (c)(1) for the lack of a comprehensive hazard analysis and HACCP plan. The letter advises referring to Chapter 18 of the Fish and Fishery Products Hazards and Controls Guidance for appropriate controls. Failure to correct this violation may result in product seizure and/or injunction against the firm's operations. Kettle Cuisine, LLC was required to respond within fifteen working days, outlining corrective actions, including revised