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Lupin gets inspection closure report from USFDA for Pithampur plant

The inspection for the facility was conducted by the US health regulator between February 3 and February 11, 2020, and concluded with two observations, the Mumbai-based company said.

April 30, 2020 / 01:17 PM IST

Drug maker Lupin on Thursday said the US health regulator has closed the inspection of its manufacturing facility in Pithampur, Madhya Pradesh.

The inspection for the facility was conducted by the US health regulator between February 3 and February 11, 2020, and concluded with two observations, the Mumbai-based company said.

The company has received the establishment inspection report (EIR) from the United States Food and Drug Administration (USFDA) for its Pithampur Unit-1 facility, Lupin said.

The USFDA issues an EIR to a company when an inspection is satisfactorily closed.

Lupin Managing Director Nilesh Gupta said the company has received the EIR for the plant with Voluntary Action Indicated (VAI) status.

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"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 working with the USFDA to manufacture and supply products of the highest quality from all our manufacturing sites," he added.

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PTI
first published: Apr 30, 2020 01:10 pm

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