FDA 483 - GlaxoSmithKline Biologicals SA - February 27, 2026

GlaxoSmithKline Biologicals SA in Wavre, Belgium, a vaccine manufacturer, was cited for significant deficiencies in its manufacturing processes and controls. Observations included failures in computer system accuracy checks, use of non-validated manufacturing parameters, inadequate aseptic process validation, and insufficient environmental monitoring in sterile production areas. These issues indicate a lack of robust quality control and adherence to established procedures, potentially impacting drug product quality and sterility.