FDA 483 - GlaxoSmithKline Biologicals SA

GlaxoSmithKline Biologicals SA, a vaccine manufacturer in Rixensart, Belgium, was cited for multiple deficiencies during an FDA inspection. Observations included inadequate laboratory controls, insufficient investigation into Water for Injection contamination, deficient corrective actions, and poor equipment maintenance. These issues indicate a need for improved quality systems and adherence to manufacturing standards.