Franklin Foods Inc. – FDA Warning Letter, Oct 26, 2010

The FDA issued a Warning Letter to Franklin Foods, Inc. following an inspection of their Enosburg Falls, Vermont facility from September 16 to October 26, 2010. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) concerning the manufacturing of smoked salmon cream cheese, rendering the products adulterated due to insanitary conditions. Specific HACCP deficiencies included the firm's plan failing to list Clostridium botulinum and food allergens as reasonably likely food safety hazards. Additionally, the HACCP plan lacked a specified monitoring frequency for the "storage" critical control point to control pathogens, and its corrective action plan for this critical control point was deemed inappropriate. Furthermore, environmental swabs collected during the inspection detected Listeria monocytogenes on non-food contact surfaces, highlighting insanitary conditions. The firm's written response to the inspection was found inadequate, as it failed to provide sufficient details on controlling refrigerated storage through continuous monitoring and lacked a comprehensive plan for reassessing their Listeria monitoring program, including updated sampling criteria and increased sampling of product contact areas. Franklin Foods Inc. is required to notify the FDA within 15 working days of the specific steps taken to correct these violations. Failure to promptly correct these issues may result in further regulatory action, including product seizure or injunction, emphasizing the firm's responsibility to comply with the Federal Food, Drug, and Cosmetic Act, seafood HACCP, and Current Good Manufacturing Practice regulations.