Ochsner Health System Blood Bank – FDA 483, Mar 31, 2022

An FDA inspection of Ochsner Health System Blood Bank in New Orleans, LA, revealed three significant observations. The firm failed to consistently follow written standard operating procedures for blood and blood component processing, including a specific instance of not conducting platelet quality control. Additionally, the inspection noted a failure to provide adequate privacy for donor suitability interviews, which was a repeat observation, and a failure to use supplies according to manufacturer instructions during donor arm preparation.