Torrent Pharmaceuticals on Wednesday said the US health regulator has issued a Form 483 with five observations after inspecting its Gujarat-based manufacturing plant. The US Food and Drug Administration (USFDA) conducted a pre-approval inspection (PAI) and a GMP inspection at the company’s manufacturing facility in Indrad, Gujarat, from June 3 to June 12, the drug firm said in a regulatory filing. At the end of the inspection, the company was issued a Form 483 with five observations, it added.
There is no observation related to data integrity reported, Torrent Pharma 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,” it stated.
As per the USFDA, a 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.
