Tuesday, 22 October 2019

Lupin receives EIR for Pharmacovigilance inspection from the USFDA

14 May 2019 | 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 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.

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