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

An FDA inspection of the Department of the Army Blanchfield Army Community Hospital's Transfusion Service Department identified two significant observations. The facility failed to thoroughly investigate an unexplained discrepancy related to ABO blood typing and did not conduct a root cause analysis. Additionally, the firm failed to concurrently maintain records for significant steps in the storage of blood and blood components, specifically regarding the relocation of inventory from an out-of-service freezer.