FDA 483 - CSL Behring GmbH - April 30, 2024

An FDA inspection of CSL Behring GmbH in Marburg, Germany, identified significant deficiencies across its drug product manufacturing operations. Key issues include an inadequately designed aseptic process, insufficient quality oversight leading to questionable batch releases, and failures in preventing microbiological contamination. The firm also demonstrated shortcomings in environmental monitoring, visual inspection programs, cleaning procedures, and adherence to written procedures for deviation management and batch record completion.