Pharma major Lupin announced the receipt of the Establishment Inspection Report (EIR) after closure of the US FDA inspection of its Mandideep Unit II facility, classifying the inspection as Voluntary Action Indicated. The inspection at the facility was carried out by the US FDA between November 26, 2018 and December 4, 2018.
Commenting on the receipt of the EIR, Nilesh Gupta, Managing Director, Lupin said, “We are pleased to have received the EIR for our Mandideep Unit II facility, our important cardiovascular API manufacturing facility. We remain committed to enhancing compliance and quality standards across all our manufacturing sites.”