The US drug regulator has issued five observations related to two products from Torrent Pharmaceuticals’ Dahej plant that are awaiting approvals. A company spokesperson confirmed the development and said they would send a reply to the US Food and Drug Administration (US FDA) within the stipulated time. Analysts say there would be no immediate impact on Torrent as these products were not to be launched immediately.
US FDA officials visited the plant between June 26 and June 30 and issued observations related to discrepancies on batch distribution, written procedures, maintenance of equipment and criteria for sampling and testing, etc. Analysts noted