FDA 483 - GlaxoSmithKline Biologicals Kft. - January 31, 2025

GlaxoSmithKline Biologicals Kft. in Godollo, Hungary, a licensed biological drug manufacturer, was cited for two observations during an FDA inspection. The firm failed to adequately investigate manufacturing discrepancies, including particulate contamination and temperature excursions, by not assessing worst-case conditions. Additionally, procedures for accepting and rejecting manufacturing components were found to be inadequate, lacking proper risk assessments for materials containing foreign matter.