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| Exchange Received Time 30/08/2019 19:40:06 Exchange Disseminated Time 30/08/2019 19:40:10 Time Taken 00:00:04 | This is to inform you that US FDA had conducted an inspection at the Company's manufacturing facility located at Daman, India from 26th August, 2019 to 30th August, 2019.
At the end of the inspection, the Company has received a Form 483 with two (2) 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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