Granules has announced that the US Food and Drug Administration (FDA) has concluded a current Good Manufacturing Practice (cGMP) inspection of its finished dosage facility at Gagillapur, Hyderabad. The inspection was conducted from October 19 to October 30, 2026, and concluded with the issuance of a Form 483 containing 11 observations.

This was the first FDA inspection of the facility since the Warning Letter of February 26, 2025, which followed an inspection in August-September 2024.

None of the observations were related to data integrity or cross-contamination. The observations relate to enhancements in investigations, change control, process and equipment qualification, visual-inspection controls and documentation practices. There is no impact on manufacturing or distribution of products from the site.

Granules will submit a comprehensive response to the FDA within the stipulated 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.”