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Exchange Received Time  22/01/2018 14:04:00 Exchange Disseminated Time 22/01/2018 14:04:06 Time Taken 00:00:06 | This is to inform you that the US FDA has completed inspection of Company's API facilities Unit-I and Unit-II located at Raichur, Karnataka, India which was inspected between 16th January and 19th January 2018. The inspection has now been closed by the US FDA with three 483 observations. The Company is in the process of submission of corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines in response to the form 483 issued at the end of inspection. This is for your information and doing the needful. |
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