Alkem Laboratories has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA), for its St Louis facility, USA. The inspection has been closed by the USFDA.
Earlier, the inspection was conducted by the USFDA from January 27, 2020 to February 6, 2020. At the end of the inspection, the company had received Form 483 with three 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.