FDA 483 - Department Of Defense - Air Force - March 07, 2019

The Department of The Air Force's Transfusion Service in Travis Afb, CA, was cited for failing to consistently follow its written standard operating procedures for the storage of blood and blood components. Specifically, the facility did not document receiving temperatures for blood component shipments and failed to move affected products into quarantine storage during a computer system downtime event. This indicates a lapse in adherence to established protocols for blood product handling.