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| Exchange Received Time 12/08/2019 17:38:47 Exchange Disseminated Time 12/08/2019 17:38:56 Time Taken 00:00:09 | The Company has received a communication from the USFDA classifying the inspection conducted at its Indrad facility in April, 2019 as Official Action Initiated (OAI).
The Company already had submitted its initial response to USFDA and commitments given in response to Form 483 observations have been fulfilled. The Company is sending further updates over receiving of this OAI letter. The Company will be engaging with the regulator and is fully committed in resolving this issue at the earliest.
The Company does not believe that this inspection classification will have an impact of disruption of supplies or the revenues from operations of this facility.
This is for your information and record. |
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