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| Exchange Received Time 10/03/2017 18:57:22 Exchange Disseminated Time 10/03/2017 18:57:28 Time Taken 00:00:06 | | Sub: Update on US FDA Inspection at Alkem's Baddi Facility This is to inform you that US FDA had conducted an inspection at the Company's manufacturing facility located at Baddi, India from 2nd March, 2017 to 10th March, 2017. In this regard, the Company has received the inspection report which contains three 483 observations. The Company shall put together a detailed response with adequate corrective and preventive measures to address the US FDA Observations and the same is proposed to be filed within the timeline stipulated by US FDA. Kindly take note of the same. |
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