Finished dosage facility of Granules in Hyderabad gets 11 U.S. FDA observations

Generic drugmaker Granules India’s finished dosage facility in Gagillapur, Hyderabad, has been issued 11 observations by the U.S. Food and Drug Administration (USFDA) following an inspection.

Conducted from October 19-30, the current good manufacturing practice inspection (CGMP) concluded with the issuance of a Form FDA 483 containing eleven observations. It was the first U.S. FDA inspection, of the facility, since the February 26, 2025, warning letter that 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 India said on Friday (October 30, 2026) evening.

It will be submitting a comprehensive response to the U.S. FDA within the stipulated 15 business days, the company 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,” said Krishna Prasad Chigurupati, Chairman and Managing Director.