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| Exchange Received Time 11/10/2017 17:21:55 Exchange Disseminated Time 11/10/2017 17:22:04 Time Taken 00:00:09 | This is with reference to our letters dated April 21, 2017 to the stock exchanges providing our clarification on the US FDA inspection at the Company's Dadra facility wherein interalia we had indicated that we were then in the process of responding to the Form-483 observation letter issued by the US FDA post the inspection completed on April 13, 2017. We had further stated that if there are any material developments related to this inspection, we will promptly inform the stock exchanges.
We are now pleased to inform you that the above referred inspection is closed. In this respect ,we have received a communication from the US FDA releasing a copy of the Establishment Inspection Report (EIR) in respect of the above inspection based upon our responses to the said observation letter. Please note EIR is issued to the entity when the US FDA concludes that an inspection is closed under Title 21 Section 20.64 (d) (3) of Code of Federal Regulation.
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