Lupin Limited on May 27, 2016 announced today that it has received Establishment Inspection Reports (EIR) for its Mandideep and Aurangabad facilities from the US Food & Drug Administration (FDA) wherein the US FDA has concluded that the inspections stand closed.
The US FDA had conducted audits at Lupin’s Mandideep facility from February 8-19, 2016 and its Aurangabad facility from January 11-15, 2016.
As stated earlier, the company had taken appropriate steps to address the observations it had received from these audits. “Having received the EIRs from the US FDA about the closure of these inspections, all observations stand addressed, and both these facilities are cGMP compliant,” Lupin said in a BSE filing on May 27, 2016.
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