483
Glenmark Pharmaceuticals LtdGlenmark Pharmaceuticals Ltd – FDA 483, Feb 14, 2025
Record Details
An FDA inspection of Glenmark Pharmaceuticals Ltd in Pithampur, India, revealed critical deficiencies in contamination control, facility segregation, and quality control. The firm failed to prevent cross-contamination due to inadequate cleaning and shared manufacturing areas for potent drugs. Additionally, there were significant issues with OOS investigations, analytical method validation, and timely completion of stability studies, indicating a systemic breakdown in quality assurance.
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ID · 1cc89a1d-cf2b-4d72-9e95-834b6d737023
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