FDA 483 - Northwestern Medicine Central DuPage Hospital - February 22, 2019

An FDA inspection of Northwestern Medicine Central DuPage Hospital in Winfield, IL, identified significant issues in their HCT/P testing laboratory and blood bank operations. The firm failed to follow manufacturer instructions for communicable disease testing, did not retain records for the required duration, and lacked a robust quality program to properly investigate and document deviations. These observations indicate a failure to adhere to core CGTP requirements and maintain adequate quality control processes.