Homegrown pharma major Lupin Ltd on Thursday said it has received establishment inspection report (EIR) from the US health regulator for its manufacturing facility at Somerset, New Jersey. The US Food and Drug Administration (US FDA) had inspected the facility in March 2022, the company said in a regulatory filing.
“The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI), it added. As per the USFDA, VAI classification is given when objectionable conditions were found and documented during the inspection but the agency is not prepared to take or recommend regulatory action.
“We are very happy to have received the EIR from US FDA with satisfactory VAI classification for our Somerset facility. 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,” Lupin Ltd CEO Vinita Gupta, CEO said. She further said, “We are committed to manufacture and supply products of the highest quality for the patients we serve.” Lupin Ltd Managing Director, Nilesh Gupta said the company remains committed to meet and exceed global standards of quality and compliance at all its manufacturing sites.
“With this positive development, we now look forward towards building a sustainable business from our Somerset facility, and carry this momentum to positive outcomes for our other sites,” he added. Last year in June the USFDA issued a warning letter to the company for its Somerset facility in the US following an inspection.