By: IPP Bureau
Last updated : July 18, 2025 8:46 pm
The company is addressing these observations comprehensively
The U.S. FDA inspected Lupin's Pithampur Unit-2 manufacturing facility from July 08 to July 17, 2025. The inspection closed with the issuance of a Form-483 with four observations.
The company is addressing these observations comprehensively and will respond to the U.S. FDA within the stipulated timeframe. Lupin upholds quality and compliance with utmost importance and are committed to be compliant with CGMP quality standards across all our facilities.