The inspection were carried out at Somerset facility in New Jersey
Lupin said the US health regulator has issued 13 observations after inspection of its subsidiary’s Somerset facility in New Jersey.
In a regulatory filing, Lupin said the inspection by US Food and Drug Administration (US FDA) commenced on September 10, 2020, and concluded on November 5, 2020. The duration of the inspection was prolonged due to COVID-related delays and challenges.
The inspection has closed with 13 observations, it said.
“We are confident of addressing these observations and will work closely with the agency to address their concerns,” the company said.
Lupin said it does not believe that this will have an impact on disruption of supplies or the existing revenues from operations of this facility.
The facility contributes less than 5 per cent of our global revenues, it added.