Torrent Pharmaceuticals on Friday said the US health regulator has issued a Form 483 with one observation after inspecting its Pithampur-based manufacturing facility. The US Food & Drug Administration (USFDA) conducted a routine GMP inspection of the company’s formulation manufacturing plant at Pithampur, Madhya Pradesh from September 16-20, the drug maker said in a regulatory filing.
“At the end of the inspection, the agency issued a Form FDA 483 with one observation which is procedural in nature,” it added.
The drug maker will respond to the USFDA within the prescribed timeframe and will work in close collaboration with it to address the observation at the earliest possible time, the company said.
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.
Torrent Pharma shares were trading 2.97 per cent higher at Rs 3,450 apiece on BSE.
