483
New York Blood Center EnterprisesFDA 483 - New York Blood Center Enterprises - December 05, 2025
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Record Details
New York Blood Center Enterprises in Melville, NY, a donor center, received a Form 483 following an FDA inspection. Observations included failures to adhere to manufacturer instructions for blood collection systems and to establish, maintain, and follow written standard operating procedures. Additionally, the firm's records were found to be incomplete, lacking proper identification of personnel performing work.
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ID · c1db49b5-3e4b-4ede-8ee2-1a5a0a2f9f52