US FDA issues Form 483 to Alkem Laboratories for St Louis plant

Alkem Laboratories said that it has been issued Form 483 with a couple of observations from the US Food and Drug Administration (FDA) pertaining to its manufacturing facility located in St. Louis in the US.

The FDA carried out its inspection from 6 September to 14 September 2022, said the Indian pharma company.

Alkem Laboratories said that there was no data integrity observation by the regulator, while adding that the pre-approval inspection is part of the routine business operations.

It stated: “The Company shall submit to US FDA within the stipulated timeline, a detailed response to close out the said observations.”