FDA 483 - Zurex PharmAgra, LLC - January 08, 2016

Furex PharmaGra, LLC, an animal drug manufacturer in Middleton, WI, was cited for significant deficiencies during an FDA inspection. The firm lacks an established Quality Control Unit to oversee animal drug manufacturing by its contract manufacturer. Additionally, the inspection revealed inadequate written procedures for handling, sampling, testing, and approval of components, drug product containers, and closures.