FDA 483 - CSL Plasma Inc. - June 15, 2023

CSL Plasma Inc. in Henrico, VA, a plasma center, was cited for failing to thoroughly investigate unexplained discrepancies during an FDA inspection. The firm did not investigate 27 temperature readings that exceeded the set point for a freezer used to store collected plasma. This indicates a lapse in adherence to established work instructions for temperature excursions and quality control.