FDA 483 - New York Blood Center Enterprises - February 11, 2020

New York Blood Center, Inc. in Long Island City, NY, was inspected for human cord blood processing and received a Form 483 with four observations. The inspection revealed significant issues with laboratory controls, including a lack of sound specifications and failure to follow established procedures, leading to miscalculated results for cord blood units. Additionally, the firm failed to thoroughly investigate discrepancies and had inadequate donor screening for communicable disease risk factors like Zika virus.