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Exchange Received Time  04/06/2019 17:47:24 Exchange Disseminated Time 04/06/2019 17:47:32 Time Taken 00:00:08 | This has reference to your above cited email seeking clarification on the subject matter. With reference to the above, we inform you that the United States Food and Drug Administration (US FDA / Regulator) had conducted an inspection at our Company''s Unit III, a formulation manufacturing facility located at Bachupally, Hyderabad from 13th May 2019 to 24th May 2019. In this regard, the Company has received a ''Form 483'' with ten observations. None of the observations are repetitive and are more procedural in nature. The Company will be responding to the US FDA within the stipulated time. The Form 483 will not have an impact on existing business of this facility. |
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