Alkem Laboratories gets Form 483 from US FDA for St. Louis plant

Alkem Laboratories said that the US Food and Drug Administration (FDA) has issued Form 483 to the company with two observations.

Form 483 are given by the FDA when a company is found to have violated the Food Drug and Cosmetic (FD&C) Act and related acts.

Alkem Laboratories said that the FDA had undertaken an inspection of its manufacturing facility in St. Louis from 14 June and 18th June.

In a statement to the BSE, Alkem Laboratories said: “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 gets Form 483 from US FDA for St. Louis manufacturing facility

Alkem Laboratories gets Form 483 from US FDA for St. Louis manufacturing facility. Photo courtesy of The U.S. Food and Drug Administration/Wikipedia.org.

Alkem Laboratories, which has 21 manufacturing plants in India and the US, is focused on pharmaceutical generics, formulations, and nutraceuticals.

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