The United States Food and Drug Administration (USFDA) has completed a current Good Manufacturing Practice (CGMP) inspection of Granules India’s finished dosage facility at Gagillapur, Hyderabad. The inspection was conducted from October 19, 2026 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 India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).
