FDA 483 - New York Blood Center Inc - December 12, 2025

An FDA inspection of New York Blood Center Enterprises' donor center in Massapequa, NY, revealed significant deficiencies in adherence to manufacturer instructions for blood collection supplies and reagents. The inspection also identified failures in establishing, maintaining, and following written standard operating procedures for blood collection, as well as inadequate quality control and general record-keeping practices. These issues indicate a need for improved procedural compliance and documentation to ensure the safety and quality of collected blood and blood components.