Mumbai, : Pharma major Lupin Limited (Lupin)said that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US 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 January 14, 2019 and January 18, 2019, company release
said.
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.
UNI.
