FDA WARNING_LETTER - Bluegrass Dairy and Food Inc - September 25, 2013

The FDA conducted inspections of Bluegrass Dairy and Food, Inc.'s whey powder manufacturing facility in Glasgow, KY, on August 20-21 and September 16-18, 23, and 25, 2013. These inspections, along with a previous one on January 29-30, 2013, identified the presence of *Salmonella* in the facility's processing areas.

Specifically, laboratory analysis of environmental samples from the August/September 2013 inspections found *Salmonella* in four subsamples from the (b)(4) manufacturing room: the control panel box near the bagging room door, the wall and ridge near the (b)(4) entry door, the rotary dryer's base support, and the liquefier control panel. Pulsed-Field Gel Electrophoresis (PFGE) analysis showed that *Salmonella* isolates from the January 2013 inspection were indistinguishable from those found in August 2013, indicating the likely persistence of *Salmonella senftenberg* in a niche environment.

The FDA determined that the food products processed at the facility are adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 342(a)(4)], as they were prepared, packed, or held under insanitary conditions.