FDA 483 - Scott & White Memorial Hospital - May 07, 2019

Scott & White Memorial Hospital's blood bank in Temple, TX, was cited for two significant issues during an FDA inspection. The firm failed to concurrently maintain records for the processing, storage, and distribution of blood components, leading to traceability problems. Additionally, the inspection revealed a failure to thoroughly investigate, correct, and timely close numerous unexplained discrepancies and occurrence reports.