By: IPP Bureau
Last updated : August 09, 2023 1:30 pm
The inspection was conducted at its Goa, Vema manufacturing facility
Marksans Pharma Ltd has announced that the United State Food and Drug Administration (US FDA) has completed a post-marketing Adverse Drug Experience (PAD E) inspection. The inspection closed with two observations.
The inspection was conducted at its Goa, Vema manufacturing facility from 31st July, 2023 to 4th August, 2023. The inspection included comprehensive scrutiny of practices and procedures for reporting of adverse events of Marksans' marketed products.
The company will submit corrective and preventive action plan (CAP A) to the US FDA in the stipulated time frame.