FDA 483 - Ortho-Clinical Diagnostics, Inc. - May 22, 2025

An FDA inspection of Ortho-Clinical Diagnostics, Inc. in Rochester, NY, revealed significant deficiencies in their quality system. The firm's software validation for Vitros diagnostic systems was found inadequate, lacking full regression testing and proper justification, which led to multiple product recalls. Additionally, the company's corrective and preventive action procedures were insufficient, failing to adequately investigate the root causes of these software-related issues.