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Alkem Lab gets 8 observations from USFDA for St Louis facility

Press Trust of India  |  New Delhi 

Drug firm Wednesday said the US health regulator has issued eight observations after inspecting its at

The (USFDA) had conducted an inspection of the company's facility at St Louis, US, from January 14 to February 5, this year in a phased manner, Alkem said in a regulatory filing.

"At the end of inspection, the company has received Form 483 that contains eight observations," it added.

The company shall submit a detailed response to the USFDA, within the stipulated timeline, with a suitable corrective and preventive measures to address the observations, said.

Shares of the company were trading 0.66 per cent down at Rs 1,882.35 on the BSE.

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Wed, February 06 2019. 16:10 IST
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