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| Exchange Disseminated Time 29/09/2016 16:12:43 | Alkem Laboratories Ltd has informed BSE that US FDA had conducted an inspection at the Company’s manufacturing facility located at Daman, India from September 20 to September 29, 2016.
In this regard, the Company has received the inspection report which contains thirteen 483 observations. The Company shall put together a detailed response with adequate corrective and preventive measures to address the US FDA Observations and the same is proposed to be filed within the timeline stipulated by US FDA. |
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