FDA 483 - New York Blood Center Enterprises - April 03, 2026

New York Blood Center Enterprises in Rye, NY, received an FDA Form 483 with eight observations related to significant deficiencies in their blood and blood component manufacturing processes. Key issues include inadequate standard operating procedures, poor record-keeping, failure to report biological product deviations, and insufficient personnel training. These findings indicate a lack of control over critical aspects of blood product quality, safety, and traceability.