Gland Pharma receives 4 observations from USFDA for Dundigal formulation facility

These observations are procedural in nature

The United States Food and Drug Administration (USFDA) has conducted an unannounced inspection on Current Good Manufacturing Practice (cGMP) at Gland Pharma Limited’s Formulation Facility at Dundigal between October 12, 2026 and October 23, 2026.

The said inspection was concluded with four Form 483 Observations. These observations are procedural in nature. The corrective and preventive actions for these observations will be submitted to the USFDA within the stipulated period. The observations issued are neither repeated observations nor related to data integrity.