FDA WARNING_LETTER - Dairy Farmers of America - September 02, 2010

The FDA inspected Dairy Farmers of America's Winthrop, Minnesota facility from August 16 to September 2, 2010, documenting serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). Environmental sampling identified *Salmonella senftenberg* in three swabs from the (b)(4) area, leading to the determination that food products were adulterated under 21 U.S.C. § 342(a)(4).

Key violations included: 1. Failure to clean and sanitize equipment to prevent contamination (21 CFR 110.35(a)): High-pressure spray foamers may atomize microorganisms, and standing water was observed in low-moisture product areas after air-drying. 2. Failure to clean and sanitize food and non-food contact surfaces with sufficient frequency (21 CFR 110.35(d) and (d)(3)): Extensive product build-up was observed in the spray dryer tote packaging room, including on the tote filling tube. 3. Employees failing to wash and sanitize hands thoroughly (21 CFR 110.10(b)(3)): Employees handled cardboard cases before touching butter blocks without washing hands.

While the firm responded on September 16, 2010, and October 15, 2010, the FDA noted that not