USFDA15 Nov 2025, 01:20 am
Divis Laboratories Ltd.: US-FDA Inspection Concludes with No 483 Observations at Unit-I Facility
AI Summary
Divis Laboratories Ltd. has announced that its Unit-I facility at Lingojigudem Village, Choutuppal Mandal, Yadadri Bhuvanagiri district, Telangana, India, underwent a general cGMP inspection by the US Food and Drug Administration (US-FDA) from November 10, 2025, to November 14, 2025. The inspection has been successfully concluded with no 483 observations, indicating full compliance with the US-FDA's cGMP regulations.
Key Highlights
- Divis Laboratories Ltd.'s Unit-I facility inspected by US-FDA from November 10, 2025, to November 14, 2025
- Inspection was a general cGMP inspection
- US-FDA inspection concluded with no 483 observations
- Indicates full compliance with US-FDA's cGMP regulations
- A positive development for the company's operations in Telangana, India