FDA 483 - New York Blood Center Enterprises - July 06, 2023

New York Blood Center Enterprises in New York, NY, was inspected and cited for multiple deficiencies related to blood and blood component collection, record-keeping, and deviation reporting. Observations included failures to follow standard operating procedures, maintain adequate records, adhere to manufacturer instructions, and report biological product deviations in a timely manner. These issues indicate significant concerns with quality control and traceability in their blood bank and donor center operations.