FDA WARNING_LETTER - Kellogg Company - February 10, 2011

On February 7-10, 2011, the FDA inspected Kellogg Company's food manufacturing facility in Augusta, GA. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR 110) and the presence of *Listeria monocytogenes* (*L. monocytogenes*).

Laboratory analyses of environmental swabs found 15 positive for *L. monocytogenes*, with seven from direct food-contact surfaces, including conveyor mesh and belts of spiral coolers. Pulsed Field Gel Electrophoresis (PFGE) showed the *L. monocytogenes* isolates were indistinguishable from those found in January 2010, indicating a persistent strain and inadequate cleaning. This renders the foods adulterated under 21 U.S.C. §342(a)(4).

Additional CGMP violations included: 1. **Plant and facilities construction (21 CFR 110.20(b)(4)):** Observed saturated insulation, pooling water from condensate drips directly into an open mixer bowl, and pooling water with product debris and a black substance at spiral cooler in-feeds. Kellogg's response outlined corrective actions like insulation removal and a "Hygienic Reset" document, but lacked completion dates for all projects. 2. **Pest exclusion (21 CFR 110.35(c)):** Approximately 20 flies