483
Glenmark Pharmaceuticals Inc USAGlenmark Pharmaceuticals Inc USA – FDA 483, Jul 26, 2019
Record Details
An FDA inspection of Glenmark Pharmaceuticals Inc., USA in Monroe, NC, revealed a significant issue regarding the prevention of microbiological contamination in sterile drug products. The firm failed to establish procedures for the periodic re-certification of HEPA filters, which is critical for maintaining air quality in controlled environments. This deficiency could compromise the sterility of their drug products.
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ID · a0d148ad-00b7-4e0e-b4b8-7335fd1e7280
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