USFDA issues ten observations for Alkem Labs Baddi facility
Mumbai: Alkem Labs has announced that the U.S. Food and Drug Administration (USFDA) has issued Form 483 with ten observations at the end of the inspection at the Company’s manufacturing facility located at Baddi. USFDA inspected the facility from 19th March, 2024 to 27th March, 2024. This was a GMP as well as a Pre-Approval Inspection. “There is no […]