NEW DELHI, May 27: Drug maker Lupin Monday said the US health regulator made two observations after inspection of its Goa 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 Goa facility between January 28 to February 8, 2019 as Official Action Indicated (OAI)… The inspection at the Goa facility had closed with two observations, Lupin said in a regulatory filing.
“The USFDA 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 USFDA and is hopeful of a positive outcome, it added.
Earlier, the USFDA 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.
(PTI)
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