FDA 483 - CSL Behring GmbH - February 18, 2026

CSL Behring GmbH in Marburg, Germany, was cited for significant quality control and complaint handling deficiencies during an FDA inspection. The firm failed to adequately manage changes to stopper materials, leading to product complaints and patient impact, and did not properly investigate or report these issues. Additionally, deficiencies were noted in equipment cleaning validation and the timely completion of quality investigations.