FDA 483 - GlaxoSmithKline Manufacturing S.p.A. - May 15, 2025

An FDA inspection of GlaxoSmithKline Manufacturing SpA, a drug substance and drug product manufacturer, revealed significant issues with environmental control and sterilization processes. The firm failed to adequately control mold in classified production rooms, showing an increasing trend of mold recoveries and ineffective corrective actions. Additionally, the acceptance criteria for biological indicators used in sterilization cycles were found to be insufficient to ensure proper sterility assurance.