Lupin announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its Goa manufacturing facility, after the inspection of the facility in September 2021.
The facility’s inspection categorization has been identified as Voluntary Action Indicated by the US FDA (VAI).The FDA has changed the facility’s inspection classification to Voluntary Action Indicated.
“We are very happy to have received the EIR from USFDA 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.
“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, ”commenting on the development, Nilesh Gupta, Managing Director, Lupin said.