FDA 483 - SmithKline Beecham Pharma GmbH & co. KG (dba GlaxoSmithKline Biologicals) - March 15, 2024

An FDA inspection of SmithKline Beecham Pharma GmbH & co. KG (dba GlaxoSmithKline Biologicals) in Dresden, Germany, revealed significant deficiencies in laboratory controls. The firm failed to establish scientifically sound test procedures for in-process materials and drug products, and improperly invalidated tests without conducting thorough investigations. These issues raise concerns about the quality and integrity of their vaccine manufacturing processes.