The U.S. FDA 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 inspection at the Goa facility had closed with two observations. Based on U.S. FDA's Concept of Operations program, the Company understands that the status of the facility is still under review. The Company does not believe that this inspection classification will 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 U.S. FDA and is hopeful of a positive outcome.
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