Granules Gagillapur facility completed a USFDA inspection

The USFDA inspection of

's finished dosage facility at Gagillapur, Hyderabad ran from October 19 to October 30, 2026 and concluded with a Form FDA 483 containing eleven observations, the company says. The company says none of the observations were related to data integrity or cross-contamination; it says they relate to enhancements in investigations, change control, process and equipment qualification, visual-inspection controls and documentation practices, with no impact on manufacturing or distribution from the site. Granules says it will submit a comprehensive response to the USFDA within the stipulated 15 business days. Chairman and Managing Director Dr. Krishna Prasad Chigurupati said the inspection progressed constructively and the observations are of a nature the company believes can be fully addressed through its responses and corrective and preventive actions. USFDA issued a Form FDA 483 with eleven observations after inspecting the Gagillapur finished dosage facility.