Osage Lane Creamery LTD – FDA Warning Letter, Jun 16, 2015

On December 3, 2015, the FDA issued a Warning Letter to Osage Lane Creamery, LTD, following an inspection of their raw goat milk Feta cheese manufacturing facility from May 21, 22, and June 16, 2015. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110) and the presence of *Listeria monocytogenes* in environmental samples.

FDA laboratory analysis confirmed *L. monocytogenes* in one of 73 environmental swabs taken on May 21, 2015, from the processing room floor. This was a recurring issue, as previous samples from a July 2012 inspection also tested positive for *L. monocytogenes*. This indicates inadequate sanitation efforts to control pathogens.

Violations of 21 CFR Part 110 included: 1. Failure to prevent contamination from production procedures (21 CFR Part 110.80): An employee placed milk cans directly on the floor, and a hose used to rinse cans (touching the inside) was subsequently used to spray the manufacturing kettle. Insanitary conditions observed included standing water, dead insects, spiders, and dirt/debris on storage buckets. 2. Failure to protect work-in-progress from contamination (21 CFR Part 110.80(b)(