FDA 483 - Glenmark Pharmaceuticals Inc USA - July 26, 2019

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.