Lupin receives EIR for Pharmacovigilance inspection from the USFDA

May 14, 2019 | Tuesday | News

The inspection was conducted at Lupin’s global pharmacovigilance group DSRM (Drug Safety & Risk Management)

Pharma major Lupin Limited (Lupin) 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 14^th January, 2019 and 18^th 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.