FDA 483 - GlaxoSmithKline Biologicals SA - February 27, 2026

GlaxoSmithKline Biologicals SA in Rixensart, Belgium, a licensed biological drug manufacturer, was cited for significant deficiencies in its environmental monitoring program. Observations included a failure to verify the effectiveness of corrective actions following environmental monitoring action limit excursions and a lack of procedures for assessing the impact on drug substance batches. Additionally, the firm failed to routinely monitor temperature and humidity in aseptic processing areas for Hepatitis B vaccine production, contrary to its own written procedures and without scientific justification.