FDA 483 - Saint Vincent Hospital Sisters Third Order of Saint Francis - October 29, 2024

Saint Vincent Hospital Sisters Third Order of Saint Francis in Green Bay, WI, a hospital transfusion service, was cited for significant deficiencies in record-keeping practices during the distribution of blood and blood components. The inspection revealed failures to document returns, temperature conditions, and issuing technicians for packed red cell units, including those issued as emergency uncrossmatched units. These issues indicate a lack of traceability and control over critical steps in blood product handling.