FDA 483 - Aultman Hospital - January 24, 2020

Aultman Hospital, a blood bank in Canton, OH, was inspected by the FDA from January 13-24, 2020. The inspection revealed that written standard operating procedures for blood and blood component processing, testing, storage, and distribution were not consistently followed. This led to numerous instances of missing documentation for blood unit dispositions, transfusion times, and post-transfusion observations, with no documented corrective actions to prevent recurrence.