FDA 483 - Bio-Rad - March 07, 2023

Bio-Rad in Steenvoorde, France, was cited for multiple deficiencies related to its manufacturing processes and quality system for biologic IVD and biologic substance products. Observations included unapproved production procedures, inadequate documentation of acceptance activities, and failures in corrective and preventive actions. The inspection also found issues with the use of expired materials and insufficient equipment calibration.