FDA EIR - New York Presbyterian Hospital Services - August 21, 2023

An FDA Level II inspection of New York Presbyterian Hospital Services' blood bank was conducted from August 18-21, 2023. This inspection was part of the Office of Biological Operations' FY23 blood work plan, following guidance for licensed and unlicensed blood banks. The hospital operates as a blood bank, irradiating 100% of its blood and blood components, and recently opened a new blood bank facility in the Alexandra Cohen Hospital for Women and Newborns, with all new equipment and software validated successfully. Crucially, the inspection concluded with a "No Action Indicated" (NAI) classification, meaning no significant violations were found, and no FDA Form 483 (Inspectional Observations) was issued. Review of quality assurance, product testing, component preparation and labeling, and quarantine/storage systems revealed no major deficiencies. Records pertaining to irradiation procedures, equipment validation, continuous monitoring systems, transfusion reactions, and Blood Product Deviation Reports (BPDRs) were found to be adequate and complete. The firm had submitted five BPDRs and one fatality report since the last inspection, all handled with timely reporting and appropriate investigations. The only administrative recommendation was a reminder to thoroughly review and ensure their FDA registration accurately reflects current operations, which management committed to addressing.