FDA 483 - CSL Behring (Australia) Pty Ltd - March 08, 2024

CSL Behring (Australia) Pty Ltd was inspected regarding its drug substance manufacturing, revealing significant issues across multiple areas. The firm failed to control mold in manufacturing areas, released a drug substance batch with a major process deviation based on an inadequate risk assessment, and exhibited deficiencies in laboratory data management and written procedures. These observations indicate a lack of adequate control and oversight in critical manufacturing and quality control processes.