By: IPP Bureau
Last updated : August 03, 2021 7:04 pm
The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility
Lupin Limited has received a warning letter from the U.S. FDA for the company’s Somerset, New Jersey facility.
The U.S. FDA had inspected the Lupin Somerset site from September 10, 2020 to November 5, 2020 and the company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility.
The company is committed to addressing the concerns raised by the U.S. FDA and will work with the FDA and the New Jersey District to resolve these issues at the earliest. The company upholds quality and compliance issues with utmost importance and are committed to be compliant with Good Manufacturing Practice standards across all its facilities.