FDA WARNING_LETTER - Dixie Mills, LLC - January 19, 2011

On January 13-19, 2011, the FDA inspected a food manufacturing facility in Tifton, GA, revealing serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). The inspection found significant evidence of rodent and insect activity, rendering food products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) due to insanitary conditions.

A finished product sample of Dixie Mills Old Fashioned Yellow Grits, coded "Best By May 1011," contained 213 dead insects (135 adult, 78 larvae), causing it to be adulterated under Section 402(a)(3) of the Act. While the firm disposed of this lot, no further action to identify other adulterated products or prevent recurrence was evident.

Key violations included: 1. Failure to exclude pests and protect against contamination (21 CFR 110.35(c)): Investigators observed insects "too numerous to count" (TNTC) in finished product cases and packaging, apparent rodent urine stains on product pallets, and TNTC old and fresh rodent excreta pellets throughout the warehouse, bagging room, ingredient staging area, and other processing rooms. Pest control logs showed repeated rodent activity findings without documented corrective actions by the firm. 2. Failure to maintain facilities in repair (21