483
SmithKline Beecham Pharma GmbH & co. KG (dba GlaxoSmithKline Biologicals)SmithKline Beecham Pharma GmbH & co. KG (dba GlaxoSmithKline Biologicals) – FDA 483, Mar 15, 2024
Record Details
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.
- Inspection date
- March 15, 2024
- Product type
- biologics
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ID · 844c9c7a-b8f2-438a-8fe3-d89cb297cebc
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