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

CSL Plasma Inc. in District Heights, MD, a Source Plasma Establishment, was cited for two significant observations during an FDA inspection. The firm failed to prevent the release of unsuitable Source Plasma units from donors with failed protein tests for further manufacturing into injectable products. Additionally, the company did not properly notify donors of positive test results for relevant transfusion-transmitted infections, omitting critical test information from notification letters.