“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,” it added.
Lupin is committed to addressing the concerns raised by the USFDA and will work with the FDA and the New Jersey district to resolve these issues at the earliest, the filing said.
“We uphold quality and compliance issues with utmost importance and are committed to be compliant with ‘good manufacturing practice’ standards across all our facilities,” it added.
When USFDA finds that a manufacturer has significantly violated FDA regulations, it notifies the manufacturer. This notification is often in the form of a warning letter.
Earlier, in November 2020, Lupin in a regulatory filing had said that the USFDA had issued 13 observations after the inspection of its subsidiary’s Somerset facility.
The company had said that it was confident of addressing these observations and would work closely with the agency to address their concerns.
The facility contributes less than 5 per cent of the company’s global revenues, Lupin had said.