483
Blood Bank Of Delmarva, a Division of New York Blood Center, Inc.FDA 483 - Blood Bank Of Delmarva, a Division of New York Blood Center, Inc. - February 11, 2020
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Record Details
An FDA inspection of Blood Bank Of Delmarva, a Division of New York Blood Center, Inc. in Newark, DE, revealed significant issues with donor notification procedures. The firm failed to inform a donor of their deferral status and the reason, specifically after a reactive Anti-HIV-2 EIA test. Additionally, the blood bank did not provide adequate information regarding medical follow-up and counseling to the affected donor.
- Inspection Date
- February 11, 2020
- Product Type
- Biologics
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ID · 58e74635-f6bc-4510-8716-f59f437dcd7a