Marksans has announced that the United State Food and Drug Administration (US FDA) has completed a post-marketing adverse drug experience (PADE) inspection. The inspection closed with two observations.
The inspection was conducted at its Goa, Vema manufacturing facility from July 31, 2023 to August 4, 2023. The inspection included comprehensive scrutiny of practices and procedures for reporting of adverse events of Marksans’ marketed products.
We will submit corrective and preventive action plan (CAPA) to the US FDA in the stipulated time frame.