FDA WARNING_LETTER - El Toro Farm Fresh Cheese Co. - January 25, 2012

On January 23-25, 2012, the FDA inspected El Toro Farm Fresh Cheese Co.'s soft cheese facility in Piedmont, SC, revealing serious Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 110). These violations render their soft cheese products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, due to insanitary conditions.

Observed violations include: * **Equipment and Utensils (21 CFR 110.40(a)):** Cheese drain trays had rough-edged holes, cheese molds were made of corrosive galvanized metal (repeat violation), and a raw product hose had an uncleanable ribbed surface with grime. * **Instrument Maintenance (21 CFR 110.40(f)):** Failure to calibrate thermometers for batch pasteurization and finished product coolers (repeat violation). * **Sanitary Facility Maintenance (21 CFR 110.35(a)):** Dirt, debris, and cobwebs on walls, floors, and ceilings (repeat violation); grime on temperature recorder wires above the pasteurizer (repeat violation); grime and milk buildup on internal pasteurizer components (repeat violation); buildup on pasteurizer lids, pump, and hose (repeat violation); and hand sinks with open corrugated seams. * **Non-Food-Contact Surface Cleaning (21