The United States Food and Drug Administration (USFDA) conducted a pre-approval inspection (PAI) at the company’s oral-oncology manufacturing facility located in Bileshwarpura, Gujarat from December 5 to December 11, and issued five procedural obeservations for the same.

The USFDA has issued Form 483 with five procedural observations for Torrent Pharma's oral-oncology facility in Gujarat, the latter said in a stock exchange filing.

The company added there was no observation related to data integrity reported.
 

The United States Food and Drug Administration (USFDA) conducted a pre-approval inspection (PAI) at the company’s oral-oncology manufacturing facility located in Bileshwarpura, Gujarat from December 5 to December 11, the stock exchange filing stated.

"At the end of the inspection, the company was issued a Form 483 with 5 procedural observations, " Torrent Pharma said, adding that it would respond to the USFDA within the mentioned timeframe and will closely collaborate with it to resolve the observations.