Gland Pharma Limited has announced the conclusion of an unannounced inspection by the United States Food and Drug Administration (USFDA) at its Dundigal formulation facility. The inspection, conducted between October 12, 2026, and October 23, 2026, resulted in four procedural observations. The company stated these observations are not repeated and do not pertain to data integrity. Gland Pharma will submit corrective and preventive actions within the stipulated period.
USFDA Inspection Concludes at Dundigal Facility
Gland Pharma Limited has officially informed stakeholders about the conclusion of an unannounced inspection conducted by the United States Food and Drug Administration (USFDA). The inspection focused on Current Good Manufacturing Practice (cGMP) standards at the company’s Formulation Facility located in Dundigal. The inspection period ran from October 12, 2026, through October 23, 2026.
Inspection Findings and Next Steps
The inspection resulted in the issuance of four (4) Form 483 Observations. Gland Pharma has clarified that these observations are procedural in nature. Crucially, the company stated that the issued observations are neither repeated from previous inspections nor related to data integrity. Gland Pharma is committed to addressing these findings and will submit its corrective and preventive actions to the USFDA within the designated timeframe.
Commitment to Compliance
The company assures that it will implement necessary actions to ensure ongoing compliance with regulatory standards. Further details regarding the required disclosures as per SEBI regulations are provided in Annexure A, which accompanies this announcement.
Source: BSE
