FDA 483 - CSL Behring (Australia) Pty Ltd

An FDA inspection of CSL Behring Australia Proprietary Ltd, a manufacturer of plasma derivatives, revealed significant deficiencies in their manufacturing process controls. The firm failed to establish adequate procedures for monitoring the output of manufacturing processes, specifically regarding the assessment and monitoring of internal in-process control specifications for their U.S. licensed IVIG product. Additionally, the company did not submit required Biological Product Deviation Reports for numerous complaints of cracked or broken vials.