USFDA issues Form 483 with 3 observations to Alkem Laboratories’ St Louis plant

11 Nov 2022 Evaluate

The US Food and Drug Administration (USFDA) has issued three observations after inspecting Alkem Laboratories’ St Louis-based manufacturing facility. The USFDA had conducted a pre-approval inspection at the plant from October 31, 2022 to November 9, 2022. At the end of the inspection, the company received Form 483 with three observations.

There is no data integrity observation. This pre-Approval Inspection is part of the routine business operations and the company shall submit to USFDA within the stipulated timeline, a detailed response to close out the said 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.

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