FDA 483 - Gland Pharma Limited - June 22, 2015

An FDA inspection of Gland Pharma Ltd. in Visakhapatnam, India, identified multiple significant deficiencies across its pharmaceutical manufacturing operations. Observations included inadequate media fill validation, unvalidated sterilization processes for Restricted Access Barrier systems, poor control over equipment access, and failures in environmental monitoring and alarm management. The firm also lacked proper qualification for a microbiological AutoReader, initiated stability studies late without justification, and performed manual HPLC data integration without written procedures, indicating systemic issues with quality control and adherence to good manufacturing practices.