FDA 483 - Radix Laboratories Inc - July 25, 2019

Radix Laboratories Inc, an animal drug manufacturer in Eau Claire, WI, was cited for significant deficiencies during an FDA inspection. Observations included releasing drug products before complete testing, failing to follow procedures to prevent objectionable microorganisms in non-sterile products, and inadequate quality control unit procedures regarding document control. These issues indicate a lack of adherence to quality assurance and manufacturing process controls.