Lupin Limited announced that it had received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its Somerset, NJ, manufacturing facility after the inspection of the facility in March 2022. The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI).
“This is a significant milestone for our Somerset site and an important step in our journey to build back our reputation as best in class in Quality and Compliance,” said Vinita Gupta, CEO of Lupin.
Commenting on the development, Nilesh Gupta, Managing Director, Lupin, said, “We remain committed to meeting and exceeding global standards of Quality and Compliance at all our manufacturing sites. We are very happy to have received the EIR for our Somerset facility with Voluntary Action Indicated status from US FDA,”