FDA 483 - CSL Behring L.L.C. - September 24, 2021

The FDA inspection of CSL Behring LLC in Bradley, IL, revealed significant deficiencies in aseptic processing areas, including widespread mold contamination and HEPA filter failures. The firm also failed to effectively implement corrective actions for equipment maintenance, ensure product manufacturing adhered to approved licenses, and maintain compliance with established procedures for plasma lookbacks and operator conduct. These issues collectively indicate a lack of adequate control over environmental conditions, equipment integrity, and procedural adherence, posing potential risks to product quality and safety.