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483
•Department of Defense - Navy•October 3, 2024

Department of Defense - Navy – FDA 483, Oct 3, 2024

Record Details

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
View Company Profile

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

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