FDA 483 - Emory University Hospital Midtown- Center for Transfusion & Cellular Therapies - April 28, 2017

An FDA inspection of Emory University Hospital Midtown - Center for Transfusion & C. in Atlanta, GA, revealed significant deficiencies in their blood bank and transfusion service operations. The firm failed to make timely notifications to recipients during HCV look-back investigations and did not consistently adhere to its written standard operating procedures for blood product handling, record-keeping, and tracking. These issues indicate a lack of robust control over critical processes for blood and blood component management.