FDA 483 - Ortho-Clinical Diagnostics, Inc. - December 09, 2022

This FDA Form 483 report details significant deficiencies at Ortho-Clinical Diagnostics, Inc. related to quality system controls. Observations include inadequate documentation of acceptance activities, untimely corrective actions, delayed reporting of biological product deviations, and insufficient training effectivity. The findings indicate a need for improved adherence to procedures and regulatory requirements to ensure product quality and safety.