US FDA concluded an inspection of Lupin’s subsidiary Novel Laboratories based in Somerset, NJ. The inspection 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 at the Somerset, NJ facility closed with thirteen observations. The company informed that it is confident of addressing these observations and will work closely with the agency to address their concerns.
In a statement, it said, “The Company 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 five per cent of our global revenues.”