USFDA has updated website for Aurobindo Pharma’s Unit 4 to a voluntary action indicated (VAI) status. There was some amount of trepidation on this particular unit.
It is a very important unit for Aurobindo. It is their injectables facility and they had received 9 observations in USFDA inspection which had taken place in February 2018.
With this VAI status the plant is unlikely to see a re-inspection from the USFDA similar to Halol which means approvals should start from this particular facility.
Injectable facilities are much more difficult to solve and for Aurobindo this would mean a bit of a relief.