FDA WARNING_LETTER - Kennys Farmhouse Cheese - August 08, 2012

On December 11, 2012, the FDA issued a Warning Letter to Kenny's Farmhouse Cheese following an inspection from August 6-8, 2012, at their Austin, KY facility. The inspection and subsequent laboratory analyses revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110) and confirmed the presence of *Listeria monocytogenes* (L. mono).

Environmental samples collected on August 6, 2012, showed L. mono in 29 of 85 swabs from food contact and non-food contact surfaces. Finished product samples collected on August 30, 2012, confirmed L. mono in Tomme de Nena, Kentucky Bleu, and Awe-Brie cheeses. Pulsed Field Gel Electrophoresis (PFGE) indicated the environmental and finished product isolates were indistinguishable, suggesting a persistent strain and inadequate sanitation. These findings render the products adulterated under sections 402(a)(1) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Specific CGMP violations included: - Failure to exclude pests (live and dead flies observed in various processing areas). - Failure to protect work-in-progress from contamination (employee stirring cheese curds with bare hands). - Plant construction not preventing condensate contamination (condensate dripping onto finished