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| Exchange Received Time 18/05/2018 15:21:51 Exchange Disseminated Time 18/05/2018 15:22:00 Time Taken 00:00:09 | We would like to inform that the United States Food and Drug Administration (US FDA) has conducted an inspection at Alembic Pharmaceuticals API Facility located at Karkhadi from 14th May, 2018 to 18th May, 2018. This was a scheduled inspection and at the end of the inspection, the US FDA issued a Form 483 with one observation.
The Company is preparing the response to the observation, which will be submitted to the US FDA shortly.
We request you to kindly take the same on record.
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