Lupin receives EIR from FDA for Goa inspection
11 July 2016 | News | By BioSpectrum Bureau
Lupin receives EIR from FDA for Goa inspection
Lupin also announced that the US FDA inspected its Dabhasa facility
Pharma Major Lupin has announced that it has received notification that the inspection carried out by the US FDA in July 2015 at its Goa facility is now closed and the agency has issued an Establishment Inspection Reports (EIR).
However, the responses from the March 2016 US FDA inspection and updates thereafter are still under review by the agency.
Meanwhile, Lupin also announced that the US FDA inspected its Dabhasa facility from 29th June to 6th July 2016. At the end of the inspection two 483s were issued. Both the observations are minor in nature and corrective and preventive actions were shown to the inspectors during the inspection.
The inspection has been classified as Voluntary Action Indicated (VAI).
