O.N. Diagnostics, LLC – FDA 483, Mar 17, 2026

O.N. Diagnostics, LLC in Berkeley, CA, a manufacturer, was cited for significant deficiencies in its corrective and preventive action (CAPA) procedures. The inspection revealed a failure to adequately document and verify the effectiveness of corrective actions, leading to recurring nonconformities and a systemic lack of risk-based control over their CAPA process. Additionally, the firm did not evaluate the risk of significant changes to its critical quality system processes before implementation.