FDA 483 - The Blood Center - April 17, 2019

The FDA inspected The Blood Center in New Orleans, LA, from April 15-17, 2019, and issued a Form 483. The inspection revealed significant failures to follow written standard operating procedures for the collection and processing of blood and blood components for allogeneic transfusion. These deficiencies included inadequate follow-up on donor reactions, improper physical assessments of donors, and unsanitary phlebotomy practices.