Alkem Lab gets three observations from USFDA

Alkem Lab gets three observations from USFDA

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USFDA
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Alkem Laboratories has received three observations from United States Food and Drug Administration (FDA) for St Louis facility in the US.

“US FDA had conducted an inspection of the company’s manufacturing facility located at St. Louis, USA from January 27 to February 6, 2020, Alkem Laboratories said in a BSE filing.

Also read: JB Chemicals passes USFDA inspection with one observation

The company said that it shall submit to the US FDA within the stipulated timeline a detailed response to close out all the observations associated with this inspection.

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