USFDA21 Nov 2025, 10:54 pm
Lupin Ltd Receives Form-483 with Seven Observations from U.S. FDA for Goa Facility
AI Summary
Lupin Ltd, a prominent pharmaceutical company, has disclosed that the U.S. Food and Drug Administration (FDA) has conducted an inspection at its manufacturing facility in Goa, India. The inspection, which took place from November 10 to November 21, 2025, resulted in the issuance of a Form-483 with seven observations. The company has committed to addressing these observations and responding to the U.S. FDA within the specified timeframe. Lupin Ltd is dedicated to maintaining compliance with Current Good Manufacturing Practice (CGMP) standards across all its facilities.
Key Highlights
- U.S. FDA inspection at Lupin Ltd's Goa facility
- Form-483 with seven observations issued
- Lupin Ltd committed to addressing observations and responding to U.S. FDA
- Dedication to maintaining CGMP standards across all facilities