"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," the company said in a regulatory filing.
Lupin has received the 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 filing added.
The inspection was conducted at its global pharmacovigilance group DSRM (Drug Safety & Risk Management) based out of Mumbai between 14-18 January, 2019, Lupin said.
The USFDA issues an EIR to an establishment that is the subject of an FDA or FDA-contracted inspection following the closure of the inspection.
Shares of Lupin Ltd were trading 0.18% higher at ₹802.80 apiece on BSE.
This story has been published from a wire agency feed without modifications to the text.