Bio-Rad Medical Diagnostics GmbH – FDA 483, Jun 14, 2024

Bio-Rad Medical Diagnostics GmbH in Dreieich, Germany, was inspected by the FDA from June 10-14, 2024, and received a Form 483 with five observations. The inspection revealed significant issues including inadequate risk analysis, unvalidated processes, poor control of non-conforming products, deficient corrective and preventive action procedures, and inadequately maintained document control for consumer complaints. These findings indicate a lack of robust quality system controls for medical diagnostic products.