FDA 483 - Blood Bank of Delmarva, A Division of New York Blood Center, Inc. - November 12, 2019

An FDA inspection of Blood Bank of Delmarva, A Division of New York Blood Center, Inc. in Cheverly, MD, revealed significant deficiencies in their blood and blood component distribution processes. The firm failed to consistently perform and document visual inspections of blood products prior to shipment and upon receipt. Additionally, there was a lack of adequate quality control review for production and control records before product release or distribution.