FDA 483 - The University of Kansas Health System - May 05, 2015

The FDA issued a Form 483 to the University of Kansas Hospital's Blood Bank/Hospital Transfusion Service following an inspection from April 29 to May 5, 2015. Observations included a failure to maintain written standard operating procedures for investigations and risk indicator assignments, as well as a failure to thoroughly investigate unexplained discrepancies such as mislabeled, expired, and improperly thawed blood products. These issues indicate significant deficiencies in quality control and documentation practices for blood and blood components.