FDA EIR - Bailey Farms, LLC - December 29, 2016

Bailey Farms, LLC, a facility in Marshall, WI, underwent an FDA inspection on December 29, 2016. The inspection focused on the company's compliance with the BSE Ruminant Feed Ban, specifically 21 CFR 589.2000, which prohibits certain animal proteins from use in ruminant feed. The facility processes dead cattle and horses, deboning meat for pet food, and segregating spinal columns, brains, and other prohibited materials for scientific research or disposal. During the inspection, no formal objectionable conditions were identified, and an FDA 483 Inspectional Observations form was not issued. The visit concluded with a "No Action Indicated" classification, signifying overall compliance with regulatory standards. However, verbal recommendations were made to management to enhance operational controls. These included implementing lot codes on freeze-dried dog food containers to ensure traceability, a critical component for product recall efficiency. Additionally, the FDA recommended developing formal written recall procedures. Management acknowledged these recommendations and committed to implementing the necessary corrections. The inspection also involved discussions on various FDA guidance documents, including those related to FSMA and recall fees.