FDA 483 - Gland Pharma Limited - July 25, 2024

An FDA inspection of Gland Pharma Limited in Hyderabad, India, identified two significant observations. The firm's quality control unit failed to adequately follow written procedures for monitoring and responding to non-viable particle count excursions. Additionally, the company did not maintain production and control records, specifically CCTV footage of aseptic processing, for the required duration after the drug product's expiration date.