FDA 483 - Donor Center Of Nybc - January 12, 2026

New York Blood Center Enterprises in Rockville Centre, NY, was inspected and received a Form 483 with four observations. The inspection revealed issues with adherence to manufacturer instructions for blood collection, inadequate record-keeping for quality control and investigations, and failures to follow and make available standard operating procedures for blood and blood component collection. These findings indicate deficiencies in operational control and documentation practices at the donor center.