FDA 483 - CSL Plasma Inc. - December 01, 2025

CSL Plasma Inc. in District Heights, MD, received a Form 483 with two observations during an inspection. The firm failed to prevent the release of unsuitable Source Plasma units for further manufacturing from donors with unconfirmed failed test results. Additionally, the company did not adequately notify donors of positive test results for transfusion-transmitted infections, including HIV, HCV, and HBV.