USFDA grants EIR to Lupin for its Goa plant

The USFDA has classified the facility as Voluntary Action Indicated (VAI)

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USFDA
Picture: Pixabay

Last Updated on December 16, 2021 by The Health Master

Mumbai: Global pharma major Lupin announced on Tuesday that it has received the Establishment Inspection Report (EIR) from United States Food and Drug Administration (USFDA) for its Goa manufacturing facility after its inspection in September 2021.

The USFDA has classified the facility as Voluntary Action Indicated (VAI), which probably hints towards closure of inspection being run by the regulatory authority.

Lupin’s Goa facility came under USFDA’s scanner after regulatory compliance issues were reported and since then it has been under its inspection.

The US FDA had earlier issued seven observations after inspecting the Goa manufacturing facility, the major exporter of the products manufactured by Lupin.

Commenting on the development, Vinita Gupta, CEO, Lupin said “We are very happy to have received the EIR from the USFDA with VAI 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.”

Speaking on the importance of EIR for Goa’s manufacturing facility, 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.”

Lupin is the third largest pharmaceutical company in the US by prescriptions with over 15 manufacturing sites, seven research centres, more than 20,000 professionals working globally.

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