NEW DELHI: Pharma major Lupin said it has received an establishment inspection report (EIR) from the USFDA on closure of inspection of its Mandideep and Aurangabad facilities.
In a BSE filing, Lupin said: “It has received establishment inspection report (EIR) for its Mandideep and Aurangabad facilities wherein the USFDA has concluded that the inspections stand closed.”
USFDA releases a copy of the EIR to the establishment that is subject of an FDA or FDA-contracted inspection when the agency determines the same to be closed.
It further said: “The USFDA had conducted audits at Lupin’s Mandideep facility from 8th to 19th February, 2016, and its Aurangabad facility from 11th to 15th January, 2016.”
Lupin said it took appropriate steps to address the observations it had received from these audits.
“Having received the EIR from the USFDA about the closure of these inspections, all observations stand addressed and both of these facilities are current good manufacturing practice (CGMP) compliant,” it added.