CSL Behring L.L.C. – FDA 483, Jun 25, 2026

CSL Behring L.L.C. in Bradley, IL, a biologic drug manufacturer, was cited for failing to thoroughly investigate unexplained discrepancies regarding drug substance/intermediate batches. Specifically, the firm did not adequately address Penicillium contamination found in intermediate batches used to produce drug products like Privigen and Zemaira, raising concerns about patient safety due to potential toxins. The investigation was found deficient in its sampling scheme and scope, failing to fully assess the extent of contamination.