Gland Pharma's Visakhapatnam Plant Issued Three Form 483 Findings by US FDA

Gland Pharma Limited made the announcement of the successful completion of a US FDA pre-approval inspection (PAI) at its JNPC plant in Visakhapatnam from February 19 to 25, 2025. The inspection led to three Form 483 findings, which the company characterized as procedural in nature. Gland Pharma clarified that the findings are not repeat and are not data integrity-related. The pharma company intends to file corrective and preventive measures to the US FDA within the prescribed timeline. This step forms part of the regulatory process of Gland Pharma's sterile APIs and does not have any immediate operational or financial impact. The company is keen on resolving the observations in a timely manner to ensure US FDA compliance continues.