FDA changes inspection classification of facility to Voluntary Action Indicated
Mumbai, December 14, 2021: Global pharma major Lupin Limited (Lupin) today announced that it has received the Establishment Inspection Report (EIR) from United States Food and Drug Administration (US FDA) for its Goa manufacturing facility, after the inspection of the facility in September 2021. The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI).
“We are very happy to have received the EIR from US FDA with Voluntary Action Indicated classification for our Goa plant. This is a significant milestone as we build back our reputation of being best-in-class in Quality and Compliance. We are committed to manufacture and supply products of the highest quality from all our manufacturing sites.” said Vinita Gupta, CEO, Lupin.
Commenting on the development, Nilesh Gupta, Managing Director, Lupin said “This is a very positive development and we are delighted with the news of the change in classification of our Goa site. The Goa site has a very important place in the U.S. market with the number of affordable, quality medicines we supply, and we now look forward to new products flowing out of the site again. We remain committed to meet and exceed global standards of quality and compliance at all our manufacturing facilities globally.”