FDA 483 - U.S. Department of Veteran Affairs Medical Center - February 23, 2022

An FDA inspection of the U.S. Department of Veteran Affairs VA Medical Center in Chillicothe, OH, identified significant deficiencies in record-keeping and adherence to standard operating procedures for blood and blood component storage. The firm failed to maintain complete temperature records for blood bank refrigerators and freezers, and did not consistently follow its own SOPs regarding deviation documentation and alarm activation settings. These issues indicate a lack of control over critical aspects of blood product management.