FDA 483 - New York Blood Center Inc - February 24, 2021

New York Blood Center Inc, a donor center in Massapequa, NY, was inspected and cited for three observations related to quality system deficiencies. The inspection revealed issues with the availability and adherence to written standard operating procedures for blood collection, as well as failures in the standardization and calibration of equipment. These findings indicate a need for improved procedural control and equipment maintenance at the facility.