FDA 483 - Gland Pharma Limited - July 25, 2024

An FDA inspection of Gland Pharma Limited, a human drug manufacturer in Hyderabad, India, from July 22-25, 2024, revealed significant deficiencies. The firm failed to adequately follow and document quality control procedures for monitoring non-viable particle count excursions. Additionally, critical production and control records, specifically CCTV footage of aseptic operations, were not retained for the required duration.