Pharma major Lupin Limited (Lupin) today announced the receipt of the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (U.S. FDA) for its Pithampur Unit-1, India facility.
The inspection for the facility was conducted by the U.S. FDA between February 3, 2020 and February 11, 2020 and concluded with two observations.
Commenting on the receipt of the EIR, Nilesh Gupta, Managing Director, Lupin said, “We are very happy to have received the EIR for our Pithampur Unit-1 facility with Voluntary Action Indicated (VAI) status.
Continuous improvement of our quality and compliance standards across all our manufacturing sites is a key focus area for the company and we are committed to work with the U.S. FDA to manufacture and supply products of the highest quality from all our manufacturing sites.”
