FDA 483 - GlaxoSmithKline Biologicals - September 13, 2022

GlaxoSmithKline Biologicals in Saint-Amand-Les-Eaux, France, was inspected from September 5-13, 2022, and cited for a significant record-keeping deficiency. The firm failed to maintain records verifying the routine inspection of equipment used in the manufacture of Zoster Vaccine Recombinant, Adjuvanted (Shingrix), and had not established replacement frequencies for this equipment. This indicates a lapse in quality control documentation for vaccine production.