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

Bio-Rad Laboratories, Inc., an IVD manufacturer in Woodinville, WA, received a Form 483 observation during an FDA inspection. The firm was cited for deficiencies in its corrective and preventive action (CAPA) system. Specifically, the company failed to consistently establish and document risk assessments for quality issues, leading to inconsistent procedures and inadequate mitigation of identified risks.