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| Exchange Received Time 20/08/2018 19:33:34 Exchange Disseminated Time 20/08/2018 19:33:41 Time Taken 00:00:07 | This is to inform you that Company's sterile ophthalmic manufacturing facility located at B-8, MIDC Industrial Area, Waluj, Aurangabad, Maharashtra had recently undergone following inspections:-
1.PIC/S Malaysia inspection started from 07.08.2018 and was completed successfully on 10.08.2018. The inspection was carried out with respect to the oral liquids and oral powders for the ROW markets and;
2.During the above PIC/S inspection, there was also an un-announced inspection by the US FDA which started on 08.08.18.
Further, there was a civil unrest on 09.08.2018. However the US FDA inspection continued from the next day i.e 10.08.2018 and was completed on 16.08.2018.
The US FDA inspection was carried out in relation to the Ophthalmics products being exported to USA market. The US FDA has made 8 observations ( 483's) for which appropriate response shall be submitted by the Company.
However, the Company continues to export its Ophthalmics products to USA market.
Kindly take the above on record.
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