FDA 483 - Bio-Rad - May 16, 2025

Bio-Rad in Steenvoorde, France, an IVD manufacturer, was inspected by the FDA from May 12-16, 2025. The inspection revealed one significant observation concerning the lack of documentation for process revalidation and incomplete risk analysis and design verification for a critical manufacturing process change. This issue impacts a peptide component used in their Geenius HIV 1/2 Supplemental Assay.