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Lupin's Goa plant may face regulatory action, says USFDA after inspection

Lupin said in a regulatory filing that the US health regulator had made two observations following the inspection and had classified the inspection as Official Action Indicated

Press Trust of India  |  New Delhi 

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Drug maker on Monday said the US health regulator made two observations after inspection of its plant and cautioned that the facility may be subject to regulatory action; and it may withhold approval of pending applications in which this facility is listed.

"The company has received a communication from the US Food and Drug Administration (USFDA), classifying the inspection conducted at its facility between January 28 to February 8, 2019 as Official Action Indicated (OAI)... The inspection at the facility had closed with two observations," said in a regulatory filing.

"The has stated that this facility may be subject to regulatory or administrative action and that it may withhold approval of any pending applications or supplements in which this facility is listed," the company added.

Based on USFDA's Concept of Operations program, the company said it understands that the status of the facility is still under review.

The Mumbai-based drug maker, however, said it does not believe that the classification would have an impact on disruption of supplies or the existing revenues from operations of this facility.

The company is in the process of sending further updates of its corrective actions to the and is hopeful of a positive outcome, it added.

Earlier, the had classified the inspection conducted at Pithampur facility and its Somerset (New Jersey) facility in April 2019 and December 2018, respectively, as OAI, which means approvals of pending applications or supplements from the site maybe withheld.

Shares of were trading 3.17 per cent lower at Rs 738.75 apiece on the

First Published: Mon, May 27 2019. 10:30 IST