Key Event Details
- United States Food & Drug Administration (US FDA) conducted a GMP inspection at the Company's Manufacturing Facility in Goa, India
- Inspection period: June 22, 2026 to June 30, 2026
- Outcome: Issued Form 483 with six observations
- Observation nature: All observations are procedural in nature
- No observation related to data integrity reported
- None of the observations are repeat observations
Company Assessment and Response
- The Company does not anticipate any impact on the supply of its commercial products
- The Company will work in close collaboration with the Agency to address the observations
- The Company will respond to the US FDA within the stipulated timeline
Additional Information
- Company reference number: 26/26-27
- Disclosure signed by Rashmi Khandelwal, Company Secretary & Compliance Officer (ACS - 28839)
- Digital signature timestamp: June 30, 2026 at 21:53:30 IST
Forward Commitment
The Company will keep the stock exchanges informed if there is any further update in this matter.