FDA 483 - GlaxoSmithKline Biologicals - March 12, 2024

GlaxoSmithKline Biologicals in Saint-Amand-Les-Eaux, France, was inspected regarding its Shingrix vaccine manufacturing. The inspection revealed significant deficiencies including delayed investigation of vial defects, inadequate equipment cleaning procedures, and failures in both reserve sample examination and timely adverse event reporting. These issues indicate a lack of thorough quality control and compliance with regulatory reporting requirements.