FDA WARNING_LETTER - Kellogg USA - October 29, 2009

On October 22-29, 2009, the FDA inspected Kellogg USA, Inc./Kellogg Company-Frozen Foods (Eggo) in Atlanta, GA, following a Georgia Department of Agriculture notification of *Listeria monocytogenes* in Eggo Buttermilk Waffles. FDA laboratory analyses of environmental swabs also found *L. monocytogenes* in the facility. Five environmental swabs tested positive, with three having a PFGE pattern indistinguishable from the GDA's positive finished product sample, indicating potential widespread contamination and niche areas. One indistinguishable swab was from a forklift wheel, raising concerns about pathogen spread.

The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110), rendering the food adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Violations included: 1. **21 CFR 110.35(a):** Employees used high-pressure water to clean equipment near exposed raw materials, causing splashing and potential contamination. 2. **21 CFR 110.37(f):** An uncovered trash cart was observed approximately six inches from exposed raw materials in the mixing room. 3. **21 CFR 110.20(b)(4):** Condensate and drippage were observed above exposed products, conveyors, and raw