
USFDA17 Jul 2025, 09:21 pm
Lupin Ltd Receives Form-483 with Three Observations from U.S. FDA at Pithampur Unit-3
AI Summary
Lupin Ltd, a prominent pharmaceutical company, has recently disclosed that the U.S. Food and Drug Administration (FDA) inspected its Pithampur Unit-3 manufacturing facility from July 07 to July 17, 2025. The inspection resulted in the issuance of a Form-483 with three observations. The company has committed to addressing these observations and collaborating with the U.S. FDA to resolve them within the specified timeframe. Lupin is dedicated to maintaining compliance with Current Good Manufacturing Practice (CGMP) quality standards across all its facilities.
Key Highlights
- U.S. FDA inspected Lupin’s Pithampur Unit-3 manufacturing facility from July 07 to July 17, 2025
- Issuance of a Form-483 with three observations
- Lupin committed to addressing the observations and collaborating with U.S. FDA to resolve them
- Dedicated to maintaining compliance with CGMP quality standards across all facilities