Alkem’s St Louis facility gets two observations from US FDA
The US FDA had conducted an inspection of the company’s manufacturing facility from 14-18, June 2021
Alkem Laboratories informed that the US FDA has issued Form 483 with two observations for its manufacturing facility located in St Louis, US. The US FDA had conducted an inspection of the company’s manufacturing facility from 14-18, June 2021.
The company also informed that it will 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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