FDA 483 - New York Presbyterian Hospital-Columbia University Med. Ctr. - November 28, 2023

An FDA inspection of New York Presbyterian Hospital-Columbia University Med. Ctr.'s Blood Bank revealed significant deficiencies across four observations. The firm failed to maintain adequate quality control and general records, including analyzer validation and reagent documentation. Additionally, standard operating procedures for blood component compatibility testing and distribution were not consistently established or followed, and records were not always maintained concurrently. Equipment calibration was also found to be non-compliant with SOPs.