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

An FDA inspection of GlaxoSmithKline Biologicals Kft. in Godollo, Hungary, a licensed biological drug manufacturer, revealed significant deficiencies in manufacturing investigations and material acceptance procedures. The firm failed to adequately investigate particulate contamination and temperature excursions, leading to the release of potentially compromised vaccine batches. Additionally, procedures for accepting components with particulate matter were found to be inadequate, lacking proper risk assessments.