Granules India Limited announced that the United States Food and Drug Administration (USFDA) has concluded a current Good Manufacturing Practice (cGMP) inspection at its finished dosage manufacturing facility in Gagillapur, Hyderabad.

The audit, which spanned from 19 to 30 October 2026, concluded with the issuance of a Form FDA 483 listing eleven observations. This marked the first agency inspection at the site since it received a Warning Letter on 26 February 2025 following a previous audit in late 2024.

The company confirmed that the USFDA observations do not involve data integrity or cross-contamination, carrying no impact on current manufacturing or distribution. The findings focus on routine procedural enhancements, including investigations, change controls, process and equipment qualifications, visual-inspection controls, and documentation practices. The company will submit a comprehensive response to the agency within the required 15 business days.

Commenting on the inspection, Dr. Krishna Prasad Chigurupati, Chairman and Managing Director, said: “The inspection progressed constructively, and the observations are of a nature that we believe can be fully addressed through our responses and corrective and preventive actions. Quality is the foundation of everything we do at Granules, and we will continue to engage transparently with the agency.”