FDA 483 - New York Blood Center, Inc. Donor Center of NYBC - March 30, 2023

The New York Blood Center, Inc. Donor Center of NYBC in Staten Island, NY, was cited for inadequate and incomplete written standard operating procedures (SOPs) related to the screening of blood donors for Transfusion-Transmitted Malaria. The SOPs failed to properly guide staff on documenting donor eligibility information and lacked procedures for handling blood collected from deferred donors, potentially impacting the safety and purity of blood components.