FDA 483 - Bio-Rad Laboratories, Inc. - January 31, 2025

Bio-Rad Laboratories, Inc. in Woodinville, WA, an IVD manufacturer, was issued a Form 483 following an inspection that identified significant deficiencies in its quality system. The firm failed to consistently establish and document risk assessments across its corrective and preventive action (CAPA) procedures. This included inconsistent risk definitions and a lack of documented risk identification and mitigation for several CAPAs.