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| Exchange Received Time 08/04/2017 14:39:57 Exchange Disseminated Time 08/04/2017 14:40:03 Time Taken 00:00:06 | | The United States Food and Drug Administration (US FDA) inspected Unit 1, manufacturing facility at Bonthapally, Hyderabad of the Company from 3rd to 7th of April 2017. At the end of the inspection, there were 2 observations given under form 483. The two observations relate to a) procedures followed for the annual quality standards record evaluation and b) cleaning and maintenance of equipment at appropriate intervals during manufacturing campaign. The Company has already initiated corrective and preventive actions for the observations and is confident of satisfying the FDA within the stipulated time. |
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