FDA 483 - Department of Defense - Air Force - April 14, 2025

The Department of Defense - Air Force, a blood bank in Dayton, OH, was cited for failing to make reasonable attempts to notify donors within 8 weeks after determining they were deferred or ineligible for donation. Specifically, one donor with a syphilis-positive donation was not notified, and another with a second HBc positive result received notification outside the required 8-week timeframe. These issues indicate a lapse in donor notification procedures for reactive test results.