FDA 483 - Bio-Rad Laboratories, Inc. - December 13, 2021

Bio-Rad Laboratories, Inc. in Woodinville, WA, a licensed in-vitro diagnostic manufacturer, was cited for two significant issues during an FDA inspection. The firm failed to adequately document corrective and preventive action activities, specifically regarding nonconformance reports for an HIV-1 Western Blot Kit. Additionally, document control procedures for batch and quality control records were not properly established and maintained.