FDA 483 - GlaxoSmithKline Vaccines Srl - January 26, 2024

GlaxoSmithKline Vaccines Srl in Sovicille, Italy, was cited for multiple significant deficiencies during an FDA inspection. The firm failed to thoroughly investigate discrepancies and batch failures, including high invalid test rates for vaccine assays and unaddressed stopper coring complaints. Additionally, the quality control unit did not fully follow procedures, employees lacked required training, and adverse drug experiences were not reported to the FDA within the mandated timelines.