FDA 483 - Princeton Community Hospital Association - July 27, 2022

Princeton Community Hospital Association's blood bank was inspected from July 25-27, 2022, revealing a significant issue with the establishment and adherence to written standard operating procedures. Specifically, new equipment was validated and put into use without prior approval from the Laboratory Medical Director, and no formal SOP existed for equipment validation. This indicates a lapse in quality assurance and procedural control.