FDA 483 - Wesley Medical Center - December 10, 2024

Wesley Medical Center, a hospital blood bank in Wichita, KS, was cited for three significant issues during an FDA inspection. The firm failed to maintain adequate records for electronic system validation and did not properly notify transfusion recipients or their representatives about the need for HIV and HCV testing and counseling following transfusions of at-risk blood components. These observations indicate serious deficiencies in record-keeping and patient safety protocols related to blood product traceability and notification.