Granules India announced that the United States Food and Drug Administration (USFDA) has concluded a current Good Manufacturing Practice 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 FDA 483 containing eleven observations.

This was the first USFDA 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 USFDA within the stipulated 15 business days.