Torrent Pharmaceuticals said that the US FDA issued Form 483 to the company with three observations post the inspection of the drug maker's Indrad-based manufacturing facility.

The company said that the United States Food and Drug Administration (US FDA) had inspected its manufacturing facility at Indrad, Gujarat from September 19, 2022, to September 28, 2022.

At the end of the inspection, the company was issued a Form 483 with three observations.

"None of these observations were related to data integrity. We will respond to the USFDA within the stipulated timeline and work closely with USFDA to address the observations at the earliest, the company said in a statement.