FDA 483 - Western Kentucky Regional Blood Ctr - April 23, 2025

Western Kentucky Regional Blood Ctr in Owensboro, KY, a blood bank, was cited for two significant issues during an FDA inspection. The firm failed to submit biological product deviation reports for distributed blood products from donors who later tested positive for communicable diseases like Hepatitis C and HIV. Additionally, the inspection revealed inadequate record-keeping for critical steps in blood processing and storage, including centrifuge program selection and inventory movements during equipment malfunctions.