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| Exchange Received Time 28/03/2018 12:46:35 Exchange Disseminated Time 28/03/2018 12:46:41 Time Taken 00:00:06 | This is to inform you that the US FDA had conducted an inspection at the Company's manufacturing facility located at Amaliya, Daman, India from 19th March, 2018 to 27th March, 2018.
Post the inspection, the Company has received a Form 483 with thirteen 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 the US FDA.
Further to this, please also be informed that the US FDA had conducted an inspection at the Company's manufacturing facility located at St. Louis, USA from 12th March, 2018 to 16th March, 2018. In response to the one Form 483 observation issued by the US FDA, the Company has submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines.
Kindly take note of the same. |
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