USFDA conducts inspection at Alkem Laboratories’ manufacturing facility in USA

20 Jun 2022 Evaluate

The United States Food and Drug Administration (USFDA) had conducted an inspection of the Alkem Laboratories’ manufacturing facility located at St. Louis, USA from June 6, 2022 to June 17, 2022. At the end of the inspection, the company has received Form 483 with three observations. The company shall submit to US FDA within the stipulated timeline, a detailed response to close out all the observations associated with this inspection.

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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