FDA 483 - CSL Behring (Australia) Pty Ltd - March 08, 2024
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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.
ID · e85da09f-016a-4786-90d3-bb6ad18323ec