Lupin has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) 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 January, 2019 and 18 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. – Business Standard