The pharma company Lupin stated that the company’s Somerset, New Jersey (USA) facility has received a warning letter from the United States drug regulator, the company said in its filing. The company added this letter will not hurt supplies from the facility.
The company stated that the United States Food and Drug Administration (U.S. FDA) issues a warning letter for the company’s Somerset, New Jersey (USA) facility.
“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 added, “We are 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 drug company informed the exchange that the FDA had inspected the Lupin Somerset site from September 10, 2020 to November 5, 2020. The duration of the inspection was prolonged due to COVID-related delays and challenges.
The company upholds quality and compliance issues with utmost importance and are committed to be compliant with good manufacturing practice standards across all their facilities.