FDA 483 - OneBlood, Inc. - April 08, 2019

OneBlood, Inc. in Marianna, FL was inspected on April 8, 2019, and cited for a significant lapse in quality assurance. The firm failed to perform a thorough investigation and adequately document the conclusions and follow-up for an unexplained discrepancy involving a donor who experienced anemia after a donation. This indicates deficiencies in their corrective and preventive action (CAPA) processes and record-keeping.