The US FDA had conducted an inspection of Alkem Laboratories Limited's manufacturing facility located at St. Louis, USA.
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US FDA Inspection at Alkem's manufacturing facility located at St. Louis, USA
The US FDA had conducted an inspection of Alkem Laboratories Limited's manufacturing facility located at St. Louis, USA from 06th June, 2022 to 17th June, 2022.
At the end of the inspection, the Company has received Form 483 with three (3) observations. The Company shall submit to US FDA within the stipulated timeline, a detailed response to close out all the observations associated with this inspection.
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