FDA 483 - CSL Behring GmbH - April 18, 2024

CSL Behring GmbH, a biologics and medical device manufacturer in Marburg, Germany, received one observation during an FDA inspection. The firm was cited for not adequately establishing procedures for corrective and preventive action (CAPA). Specifically, deficiencies were noted in the documentation and implementation of written procedures for complaint analysis and trend evaluation, indicating a significant quality system issue.