FDA 483 - GlaxoSmithKline Biologicals SA - February 27, 2026

GlaxoSmithKline Biologicals SA in Rixensart, Belgium, received a Form 483 with two observations related to environmental control. The firm failed to verify the effectiveness of corrective actions after environmental monitoring action limit excursions and lacked procedures for assessing affected drug substance batches. Additionally, the facility did not routinely monitor temperature and humidity in aseptic processing areas for Hepatitis B vaccine, contrary to its own written procedures and without scientific justification.