FDA 483 - CSL Behring GmbH - April 18, 2024

CSL Behring GmbH, a biologics and medical device manufacturer in Marburg, Germany, was inspected by the FDA. The inspection revealed deficiencies in the firm's corrective and preventive action (CAPA) procedures. Specifically, the firm failed to adequately establish and implement written procedures for the analysis and trend evaluation of complaints to identify existing and potential quality problems.