FDA 483 - University Of Texas MD Anderson Cancer Center - August 27, 2010

The University of Texas MD Anderson Cancer Center in Houston, TX, received a Form 483 for failing to report a confirmed, fatal transfusion complication to the Director, Office of Compliance, Center for Biologics Evaluation and Research (CBER) within the required 7 days. The facility also failed to follow its own internal deviation procedure for reporting such fatalities. This indicates a significant lapse in regulatory reporting and adherence to internal protocols.