FDA 483 - New York Blood Center Enterprises - December 22, 2023

New York Blood Center Enterprises, a donor center in Ronkonkoma, NY, was cited for significant deviations during an FDA inspection. Observations included failures to consistently follow written standard operating procedures for blood collection and donor selection, as well as not adhering to manufacturer instructions for supplies. Additionally, the firm's records failed to adequately identify personnel performing work, often listing "Unknown Operator."