USFDA Slams Torrent Pharma With Form 483 Citing Five Violations

Torrent Pharmaceuticals revealed that the US Food and Drug Administration (USFDA) issued a Form 483 with five observations following an inspection of its Indrad, Gujarat, manufacturing plant from June 3 to June 12. The inspection covered both a pre-approval inspection (PAI) and a Good Manufacturing Practice (GMP) inspection. The company emphasized that no data integrity issues were identified. Torrent Pharma intends to respond to the USFDA within the specified timeframe and will collaborate closely with the agency to promptly mark the observations.

“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," Torrent Pharma stated. 

According to the USFDA, a Form 483 is presented to a company's management at the end of an inspection if the investigator identifies any conditions that could potentially violate the Food, Drug, and Cosmetic (FD&C) Act and related legislation.