The US Food and Drug Administration (USFDA) has issued a form 483 with three observations to Alkem Laboratories after an inspection at its facility in Himachal Pradesh, India. The US health regulator inspected the plant from March 2 to March 10 and has issued an inspection report to the company which contains three 483 observations. The company's plant in Baddi, manufactures finished formulations.
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.