Alkem Laboratories issued FDA Form 483 for St. Louis facility

Alkem Laboratories Limited said that it has been issued Form 483 from the US Food and Drug Administration (FDA) following an inspection of its manufacturing facility in St. Louis, Missouri.

The FDA has made three observations from its inspection that was held between 6 June 2022 and 17 June 2022, said the Indian pharma company.

Alkem Laboratories issued FDA Form 483 for manufacturing facility in St. Louis. Photo courtesy of Bluerasberry/Wikipedia.org.

Alkem Laboratories said that it will submit a detailed response to the FDA within the stipulated timeline for closing out all the observations related to the inspection.