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Exchange Received Time  18/09/2017 09:40:45 Exchange Disseminated Time 18/09/2017 09:40:54 Time Taken 00:00:09 | 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 11th September, 2017 to 15th September, 2017. In this regard, the Company has received the inspection report which contains two 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. |
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