The US Food and Drug Administration (USFDA) has issued an Establishment Inspection Report (EIR) for Alkem Laboratories’ manufacturing facility located at Baddi, which was inspected from May 13, 2019 to May 17, 2019. The inspection has now been closed by the USFDA. In response to the Form 483 issued by the USFDA containing four observations, the company had submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines.
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.