FDA 483 - Department of Defense - Air Force, 99th Medical Group - March 27, 2025

An FDA inspection of the Department of Defense - Air Force, 99th Medical Group blood bank in Nellis AFB, NV, revealed significant deficiencies. Observations included inadequate testing of a new computer system, failure to submit biological product deviation reports within the required timeframe, and incomplete documentation of investigations into unexplained discrepancies and product failures. These issues indicate a need for improved quality control and documentation practices.