FDA 483 - New York Blood Center Enterprises - September 29, 2017

An FDA inspection of New York Blood Center, Inc. in Long Island City revealed significant deficiencies in their blood bank operations. Observations included failures to establish and follow adequate standard operating procedures for blood product irradiation and donor physical examinations, as well as issues with maintaining proper temperatures during Red Blood Cell shipments. Additionally, the firm lacked sufficient documentation for the validation of its electronic health history questionnaire and exhibited discrepancies in concurrent record-keeping for blood component processing.