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

Conducted from October 19-30, the current good manufacturing practice inspection (CGMP) concluded with the issuance of a Form FDA 483 containing eleven observations. Photo courtesy: granulesindia.com 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. Published - October 31, 2026 03:26 pm IST