Homegrown pharma major Lupin Ltd on Tuesday said it has received the Establishment Inspection Report (EIR) from US Food and Drug Administration (USFDA) for its Goa manufacturing facility after an inspection in September 2021 with Voluntary Action Indicated (VAI).
The USFDA has determined that the inspection classification of the facility is VAI, the company said in a statement.
Under VAI, while objectionable conditions were found and documented during an inspection, the agency is not prepared to take or recommend regulatory action, as per the USFDA.
Commenting on the development, Lupin Chief Executive Officer Vinita Gupta said, "We are very happy to have received the EIR from the 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."
She further said, "We are committed to manufacture and supply products of the highest quality from all our manufacturing sites."
Terming the development as a "very positive" one, Lupin Managing Director Nilesh Gupta said, "The Goa site has a very important place in the US market with the number of affordable, quality medicines we supply, and we now look forward to new products flowing out of the site again."
Earlier in September this year, Lupin had said that the USFDA conducted an inspection at the Goa facility and closed with seven observations. The inspection was carried out from September 6 to September 18, 2021.