Gets thirteen 483 observation in inspection report
Alkem Laboratories announced that US FDA had conducted an inspection at the Company's manufacturing facility located at Daman, India from 20 September to 29 September 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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