FDA cites eleven observations at Granules India's Hyderabad dosage plant

US FDA issued eleven observations to Granules India's finished‑dosage plant in Gagillapur, Hyderabad after a current good manufacturing practice inspection held from Oct 19‑30, 2026. The inspection was the first FDA visit since a warning letter dated Feb 26, 2025 that followed an earlier review in Aug‑Sep 2024. None of the observations involve data‑integrity or cross‑contamination issues; they focus on improving investigation records, change‑control procedures, qualification of processes and equipment, visual‑inspection controls and documentation practices. Granules India said on Oct 30, 2026 there is no impact on manufacturing or distribution of products from the site. The company will submit a detailed response within the required 15‑business‑day window. "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. FDA’s Form 483, which lists the observations, was issued at the close of the inspection. Granules India plans to implement corrective steps and update its quality systems accordingly.

Context

US FDA inspections of overseas drug manufacturers aim to ensure that products meet U.S. safety standards. A Form 483 signals concerns that must be corrected, but it does not automatically halt production unless serious violations are found.