Granules India Ltd receives 11 Form FDA 483 observations after USFDA inspection of its Gagillapur finished-dosage facility
- First inspection at the facility since the February 26, 2025 Warning Letter.
- Observations covered investigations, change control, qualification, visual-inspection controls and documentation; none concerned data integrity or cross-contamination.
- Company said manufacturing and distribution are unaffected and it will submit a comprehensive response within 15 business days.