USFDA issues Form 483 with 5 procedural observations to Torrent Pharma's Gujarat unit

New Delhi: Torrent Pharmaceuticals Ltd on Tuesday said the US health regulator has issued Form 483 with five procedural observations after inspecting its oral manufacturing facility situated at Bileshwarpura in Gujarat.

As per the US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

The USFDA conducted a pre-approval Inspection at the company's oral manufacturing facility situated in Bileshwarpura, Gujarat from December 5 to 11, 2023, Torrent Pharma said in a regulatory filing.

"At the end of the inspection, the company was issued a Form 483 with five procedural observations. There was no observation related to data integrity reported," it added.

The company also said, "we will respond to the USFDA within the prescribed time frame and will work in close collaboration with the agency to address the observations at the earliest possible time."