Alkem Laboratories has received three observations from the American health regulator after inspection of its facility at St Louis in the US. The United States Food and Drug Administration (USFDA) had conducted an inspection of the company's manufacturing facility located at St. Louis, USA from January 27 to February 6, 2020.
At the end of the inspection, the company has received Form 483 with three observations. The company shall submit to the USFDA within the stipulated timeline a detailed response to close out all the observations associated with this inspection.
Alkem Laboratories is a leading Indian pharmaceutical company with global operations, engaged in the development, manufacture and sale of pharmaceutical and nutraceutical products. The company produces branded generics, generic drugs, active pharmaceutical Ingredients (APIs) and nutraceuticals, which it markets in India and International markets.
