FDA WARNING_LETTER - Conagra Foods Inc - January 27, 2014

On January 8-10, 13-16, 21, and 27, 2014, the FDA inspected ConAgra Foods, Inc.'s sunflower seed manufacturing plant in Afton, MO, to assess compliance with Current Good Manufacturing Practice (CGMP) regulation for foods (21 CFR 110). The inspection revealed insanitary conditions, rendering food products adulterated under Section 402(a)(4) of the Food, Drug, and Cosmetic Act.

Significant CGMP violations included: 1. Failure to demonstrate effective cleaning and sanitizing procedures (21 CFR 110.35(d)(5)). Environmental swabs taken on January 15, 2014, after a cleaning, tested positive for *Listeria welshimeri* (three swabs from the panning area) and *Listeria innocua* (one swab), indicating ineffective sanitation. 2. Failure to take reasonable precautions to prevent contamination from any source (21 CFR 110.80). Employees were observed leaving and returning to production areas without changing into proper attire, potentially contaminating surfaces. Additionally, employees did not verify the proper strength of caustic foam cleaner used on food contact surfaces, as required by SOP. 3. Failure to maintain gloves in an intact, clean, and sanitary condition (21 CFR 110.10(b)(5)).