FDA 483 - Glenmark Pharmaceuticals Inc USA - June 09, 2025

The FDA conducted an inspection of Glenmark Pharmaceuticals Inc USA, located in Monroe, NC, from June 9 to June 17, 2025. The inspection focused on the company's sterile drug manufacturing practices. Key observations included significant deficiencies in procedures to prevent microbiological contamination. Specifically, the smoke study evaluation for the prefilled syringe line was inadequate, failing to properly document airflow patterns and mitigate air turbulence. Personnel monitoring was found deficient, with improper sampling techniques and deviations from established procedures. Additionally, aseptic process simulations did not accurately recreate finished product conditions, and there was a lack of scientific rationale for certain practices, such as not autoclaving gloves between batches and reduced glove integrity testing frequency. Environmental monitoring was also found lacking, with insufficient sampling of critical surfaces.

The FDA requires Glenmark Pharmaceuticals to address these violations by implementing corrective actions to ensure compliance with regulatory standards. This includes revising procedures to adequately prevent contamination, improving personnel monitoring practices, ensuring aseptic process simulations accurately reflect real-world conditions, and enhancing environmental monitoring protocols. The company is expected to provide a detailed response outlining their corrective actions and timelines for implementation.