US Food and Drug Administration (USFDA) has conducted an inspection at Alkem Laboratories’ manufacturing facility located at St Louis, USA, from January 14, 2019 to February 05, 2019. At the end of inspection, the company has received Form 483 that contains eight observations.
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.
