FDA 483 - Gland Pharma Limited - February 25, 2025

The U.S. Food and Drug Administration issued a Form 483 to Gland Pharma Limited, a sterile drug substance manufacturer in India, following an inspection conducted from February 19 to February 25, 2025. The inspection identified significant deficiencies primarily related to aseptic processing controls and manufacturing procedures, indicating non-adherence to current Good Manufacturing Practices. Key observations included an inadequate system for cleaning and disinfecting aseptic processing areas. Inspectors noted improper dousing of walls and floors with cleaning agents, leading to pooling liquids, and personnel moving between critical areas without adequate sanitization. Furthermore, disinfectant application was often deficient, lacking proper coverage and contact time. Another critical issue highlighted was the failure to establish and follow procedures to prevent microbiological contamination. This involved an inadequate airflow visualization study and a lack of documentation for cleaning and sterilization tracking of critical sterile room equipment, such as employee shoes and goggles. Finally, the FDA noted a failure to establish adequate written procedures for production and process controls. Multiple batches of a sterile active pharmaceutical ingredient repeatedly failed particle size distribution specifications. Investigations revealed issues such as insufficient process monitoring and product solution concentration problems, with proposed corrective actions largely unexecuted. These findings indicate a lack of assurance that the drug substance manufacturing process remains in a validated state. Gland Pharma Limited is required to respond to these observations with comprehensive corrective and preventive actions.