Department of the Army Blanchfield Army Community Hospital – FDA 483, May 1, 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.
- Inspection date
- May 1, 2025
- Product type
- biologics
- Person
ID · 5489b607-c2e4-4874-84cb-b564a75c2b39
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