FDA 483 - GlaxoSmithKline Vaccines Srl - January 26, 2024

GlaxoSmithKline Vaccines Srl in Sovicille, Rosia, Italy, was cited for significant deficiencies across its quality system during an FDA inspection. Observations included failures in thoroughly investigating discrepancies and batch failures, inadequate quality control unit procedures for deviation management and CAPA effectiveness, lapsed employee training for critical functions, and late reporting of numerous adverse drug experiences to the FDA. Additionally, laboratory control mechanisms were not consistently followed, impacting data integrity.