Lupin receives EIR for Pharmacovigilance inspection from the U.S. FDA

Pharma major Lupin Limited (Lupin) today announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (U.S. FDA) for the Post-marketing Adverse Drug Experience (PADE) inspection, indicating successful closure of the inspection.

The inspection was conducted at Lupin’s global pharmacovigilance group DSRM (Drug Safety & Risk Management) based out of Mumbai between 14th January, 2019 and 18th January, 2019. The inspection included a comprehensive scrutiny of practices and procedures for reporting of adverse events of Lupin’s marketed products worldwide. The inspection closed with four observations.