483
New York Blood Center EnterprisesNew York Blood Center Enterprises – FDA 483, Nov 9, 2020
Record Details
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.
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ID · 8385b3f9-128a-478b-b6b1-af023182fa15
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