FDA 483 - Department of Defense - Air Force, 99th Medical Group - March 27, 2025
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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.
- Inspection Date
- March 27, 2025
- Product Type
- Biologics
- Person
ID · 7231d86d-3d18-4301-87c7-fb8b9f7412a5