Granules India's Gagillapur facility completes USFDA inspection with eleven observations
Granules India's Gagillapur finished dosage facility in Hyderabad completed a USFDA cGMP inspection on October 30, 2026 with a Form FDA 483 carrying eleven observations.
By ScoutQuest · · 1 min read
- Inspection Outcome
- Form FDA 483 with eleven observations
- Inspection Period
- October 19 to October 30, 2026
- Response Timeline
- comprehensive response within the stipulated 15 business days
- Release
- Press release
🏭 The USFDA inspection of Granules India'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.
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More numbers
- Response period to USFDA15 business days
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