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| Exchange Received Time 23/08/2019 18:51:40 Exchange Disseminated Time 23/08/2019 18:51:45 Time Taken 00:00:05 | This is to inform you that US FDA had conducted inspections at the Company's manufacturing facilities located at St. Louis, Fenton Park, USA from 16th August 2019 to 22nd August, 2019 and Baddi, India from 19th August, 2019 to 23rd August, 2019.
At the end of the inspection, the Company has received a Form 483 with four (4) observations for the facility located at St. Louis, Fenton Park, USA and no Form 483 is received for the facility located at Baddi, India.
The Company shall put together a detailed response with adequate corrective and preventive measures to address the US FDA Observations for the facility located at St. Louis , Fenton Park, USA 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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