FDA 483 - Blood Bank Of Delmarva, a Division of New York Blood Center, Inc. - February 11, 2020

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.