Granules India Gagillapur Facility Completes USFDA Inspection
Granules India Limited announced that its finished dosage facility in Gagillapur, Hyderabad, has completed a USFDA inspection. The inspection, conducted from October 19-30, 2026, resulted in eleven observations on Form FDA 483. These observations pertain to enhancements in investigations, change control, process and equipment qualification, visual-inspection controls, and documentation practices. Importantly, none of the observations were related to data integrity or cross-contamination, and there is no impact on the manufacturing or distribution of products from the site. Granules India will submit a comprehensive response to the USFDA within 15 business days. This is the first USFDA inspection of the facility since a Warning Letter in February 2025.
Key Highlights
- USFDA inspection of Gagillapur facility concluded with 11 observations.
- No data integrity or cross-contamination issues were noted.
- Observations relate to process enhancements and documentation.
- No impact on current manufacturing or product distribution.
- Company to submit response within 15 business days.
Price Impact
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