FDA 483 - Department of the Army Blanchfield Army Community Hospital - May 01, 2025

The FDA inspected the Department of the Army Blanchfield Army Community Hospital's Transfusion Service Department in Fort Campbell, KY, and issued a Form 483 with two observations. The inspection revealed failures in thoroughly investigating an unexplained blood type discrepancy and in maintaining concurrent records for the storage and relocation of blood and blood components. These issues indicate deficiencies in quality control and record-keeping practices within the hospital's blood bank operations.