Department of Defense - NavyOctober 3, 2024

FDA 483 - Department of Defense - Navy - October 03, 2024

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The Department of Defense - Navy, a blood bank/donor center in Bethesda, MD, was cited for significant deficiencies during an FDA inspection. Observations included the use and distribution of blood products processed with unapproved centrifuges, and failures to timely notify consignees of further testing results for HCV and HIV. Additionally, donor physical examinations were not adequately performed during blood drives.

Company: Department of Defense - Navy
Inspection Date: October 3, 2024
Product Type: Biologics
Office: Baltimore District Office
Person: La-tasha M. Gunter

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ID · 65a8db81-f81a-4563-8d98-4e4daed1fc1f