FDA 483 - New York Blood Center Enterprises - November 09, 2020

An FDA inspection of New York Blood Center Enterprises in Melville, NY, a donor center, revealed deficiencies in their written standard operating procedures for blood and blood component collection. Specifically, the firm lacked a procedure for disconnecting donors during paused plasma collection and failed to follow proper technique for blood pressure checks. These issues indicate a failure to establish and follow critical procedures for allogeneic transfusion.