FDA WARNING_LETTER - Bellisio Foods Inc - December 18, 2013

The FDA inspected Bellisio Foods Inc.'s frozen entrée processing facility from November 19 to December 18, 2013, identifying serious violations of Current Good Manufacturing Practice (21 CFR Part 110) and seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123). Consequently, the firm's frozen entrées, particularly those containing shrimp, are deemed adulterated under the Federal Food, Drug, and Cosmetic Act due to insanitary conditions. The firm's January 9, 2014, response was inadequate, failing to address all concerns. A major issue is the firm's classification of its products as "not ready to eat," which FDA disputes given the fully cooked ingredients. Significant HACCP deviations include insufficient monitoring of sanitation conditions, evidenced by inadequate temperature control of processing equipment and areas, and the presence of Escherichia coli in multiple finished products, indicating filth. The revised HACCP plans also contain deficiencies: inadequate critical limits for refrigerated storage of rework sauce and for controlling pathogen growth during cooling/holding, and insufficient monitoring procedures for both cooking processes and undeclared allergens (sulfites in shrimp) at the finished product labeling CCP. The FDA recommends using its Fish & Fisheries Products Hazards & Controls Guidance. Failure to promptly correct these violations could lead to regulatory actions like seizure or injunction, and re-inspection fees will be assessed. A written response is required within fifteen working days.