FDA 483 - NYU Langone Health Hospital - August 19, 2022

An FDA inspection of NYU Hospitals Center's Blood Bank in New York, NY, revealed significant deficiencies in record-keeping, validation practices, and adherence to standard operating procedures. The observations highlight issues with tracking returned blood products, incomplete software and process validation, and failures to follow SOPs for visual inspections and documenting approvals. These findings indicate a need for improved quality system controls within the blood bank.