FDA 483 - NYU Langone Health Hospital - January 17, 2025

NYU Langone Health Hospital's Blood Bank in Mineola, NY, received a Form 483 with five observations during an FDA inspection. Deficiencies were noted in establishing and following standard operating procedures for blood product handling, maintaining traceability records for distribution, and ensuring proper temperature control during shipment. Additionally, the inspection found issues with maintaining complete processing and quality control records, and using supplies and reagents according to manufacturer instructions.