FDA 483 - GlaxoSmithKline, LLC. - September 25, 2024

An FDA inspection of GlaxoSmithKline, LLC in Conshohocken, PA, revealed significant deficiencies in their drug substance manufacturing operations. The firm failed to ensure adequate controls against contamination, properly validate manufacturing processes, and conduct thorough investigations into discrepancies. Furthermore, issues with data integrity and overall Quality Unit oversight were identified, indicating a broad lack of GMP compliance.