The US Food and Drug Administration concluded its Current Good Manufacturing Practice inspection of Granules India’s finished dosage facility in Gagillapur, Hyderabad, issuing a Form FDA 483 with 11 observations. The inspection ran from October 19 to October 30, 2026. This marks the first regulatory check of the site since the Warning Letter issued on February 26, 2025, following an August-September 2024 audit.
Crucially, none of the 11 points cited data integrity failures or cross-contamination risks. The findings focus on operational refinements: investigation protocols, change control mechanisms, process and equipment qualification, visual-inspection controls, and documentation practices. Granules India confirmed that current manufacturing and product distribution from the Gagillapur facility remain unaffected by these observations.
Chairman and Managing Director Dr. Krishna Prasad Chigurupati addressed the outcome, stating the company believes the observations can be resolved through standard corrective and preventive actions (CAPA). The firm is preparing a comprehensive response for submission to the USFDA within the stipulated 15-business-day window.
In a separate corporate update, the company incorporated Triton Farmaceutica Do Brasil Ltda, a wholly owned subsidiary in Brazil, on October 2. The entity is designated to manufacture, promote, and distribute pharmaceuticals in the Brazilian market. It has not commenced operations yet. According to the BSE filing, the incorporation proceeded under the automatic route with Reserve Bank of India approval, and the promoter group holds no direct interest in this new overseas entity.