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Lupin announces closure of US FDA audits for its Mandideep and Aurangabad facilities

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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

Lupin has announced that it has received Establishment Inspection Reports (EIR) for its Mandideep and Aurangabad facilities 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.

The company has earlier stated that it had taken appropriate steps to address the observations received from these audits. A company release informed that 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.

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