FDA 483 - CSL Behring GmbH - April 18, 2024

An FDA inspection of CSL Behring GmbH in Marburg, Germany, from April 15-18, 2024, revealed significant deficiencies in the firm's quality system. The primary concern was the inadequate establishment and implementation of procedures for corrective and preventive actions, specifically regarding the analysis and trending of complaint data. This indicates a failure to properly manage and address potential quality problems.