Alkem Laboratories Limited has informed that USFDA had conducted an inspection at the company’s API manufacturing facility located at Mandva from 27th November, 2023 to 1st December, 2023.

At the end of the inspection, the company has received Form 483 with three observations. There is no data integrity observation.

This 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.