USFDA issues EIR for Alkem Laboratories’ Baddi manufacturing facility

25 Jun 2024 Evaluate

U.S Food and Drug Administration (USFDA) has issued an Establishment Inspection Report (EIR) for Alkem Laboratories’ manufacturing facility located at Baddi, India. The Inspection has been classified as Voluntary Action Indicated (VAI) and has been closed accordingly.

Earlier, USFDA had concluded inspection at the company’s manufacturing facility located at Baddi, India. The said inspection conducted from March 19, 2024 to March 27, 2024. At the end of the inspection, the company has received Form 483 with ten observations. This was a GMP as well as a Pre-Approval Inspection. There is no data integrity observation. 

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.


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