Torrent Pharma's Gujarat Facility Gets OAI Status From USFDA
The Indian pharmaceutical company Torrent pharmaceutical has received an inspection classification status as Official Action Indicated by the USFDA for its manufacturing facility at Indrad, Gujarat, the company said in a regulatory filing on Tuesday.
The manufacturing site was first inspected on September 28, 2022, and was issued Form 483 with three observations by the top US Health regulator flagging quality as well as procedural lapses at the facility.
"We now wish to inform you that the Company has received a communication from the USFDA determining the inspection classification as “Official Action Indicated” (OAI). This inspection classification will not have an impact on existing supplies or revenues from this facility," the company said in the filing.
The pharma major said that it will continue to cooperate with the USFDA and will undertake all necessary remedial steps to resolve these issues to the satisfaction of the regulator.
The company's stock was trading 0.5 per cent lower at Rs 1587.55 a piece on Tuesday as of 13:04 IST.
