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| Exchange Received Time 31/10/2018 12:32:41 Exchange Disseminated Time 31/10/2018 12:32:45 Time Taken 00:00:04 | This is further to the intimation given by the Company dated 20th August, 2018 with respect to US - FDA inspection of it's manufacturing facility located at B-8, MIDC Industrial Area, Waluj, Aurangabad, Maharashtra.
In response to the Form 483's issued by US FDA containing 8 Observations, the Company had submitted a detailed Compliance Report to the Regulator within the stipulated time.
It is hereby informed that, the Company has received an Establishment Inspection Report (EIR) for the said Manufacturing facility, which was inspected from 10th August, 2018 to 16th August, 2018 by US FDA. The facility is considered to be acceptable with regards to current Good Manufacturing Practices (GMPs) and the inspection stands closed.
Kindly take the above on record.
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