FDA 483 - University of Texas MD Anderson Cancer Center - May 12, 2022

An FDA inspection of the University of Texas MD Anderson Cancer Center in Houston identified a significant deficiency in the handling of adverse donor reactions. The facility failed to prepare and maintain complete written reports of investigations, specifically lacking documented follow-up for a majority of reviewed donor reaction cases, including severe incidents requiring emergency medical services. This indicates a critical lapse in record-keeping and patient safety protocols.