FDA WARNING_LETTER - Finger Lakes Farmstead Cheese Company LLC - July 12, 2012

The FDA inspected Finger Lakes Farmstead Cheese Company LLC's facility from June 5-21, 2012, and July 9-12, 2012. Environmental samples collected on June 5, 2012, tested positive for *Listeria monocytogenes* (L. monocytogenes) in the brine tank, aging cooler cheese rack and board, and processing room floor drain. PFGE analysis indicated the same L. monocytogenes strain, suggesting widespread contamination. A finished product sample of Bianco Brie-style Cheese collected on June 19, 2012, also tested positive for L. monocytogenes, rendering it adulterated under 21 U.S.C. §342(a)(1). The firm stated this lot was not distributed and was destroyed.

During the July 2012 inspection, serious Current Good Manufacturing Practice (CGMP) violations were observed, causing products to be adulterated under 21 U.S.C. §342(a)(4). Violations included failure to adequately clean food-contact surfaces (wooden boards for Gouda-style cheese) and non-food contact surfaces (metal racks in the aging cave) after being informed of positive L. monocytogenes results.

Additionally, a Schuyler Gouda Cheese sample collected on June 19, 2012, showed high levels of generic *Es