FDA 483 - CSL Behring GmbH - February 18, 2026

CSL Behring GmbH received a Form 483 for multiple significant deficiencies, primarily concerning a stopper material change that was not properly evaluated or controlled, leading to increased product complaints and patient impact. The firm failed to submit required biological deviation reports and inadequately investigated complaints. Additionally, issues were noted with equipment cleaning validation and the timely completion of quality investigations.