FDA 483 - Ortho-Clinical Diagnostics, Inc. - May 10, 2019

An FDA inspection of Ortho Clinical Diagnostics in Rochester, NY, from April 29 to May 10, 2019, revealed a significant quality system deficiency. The firm failed to adequately establish corrective and preventive action (CAPA) procedures. Specifically, no CAPA was created to address the root cause of a product recall initiated in October 2018 for VITROS analyzer systems, indicating a breakdown in their post-market surveillance and quality control processes.