Aurobindo Pharma said that the US Food and Drug Administration (USFDA) inspection at its Unit IV is still open and under review.
The drug regulator has also rescinded the Voluntary Action Initiated (VAl) status given to the facility, it said.
“The Company received a communication that the inspection conducted by the US Food and Drug Administration (USFDA) at our aforesaid Unit IV, from November 4, 2019, to November 13, 2019, is still open and under review, by way of rescindment of 90-day VAl letter that was issued by them on February 18, 2020,” Aurobindo Pharma said in a regulatory filing on Friday.
On Wednesday, the drug major informed the receipt of the Establishment Inspection Report with Voluntary Action Initiated (VAI) status from the US drug regulator. The USFDA issued the report after concluding an inspection at the drug manufacturer’s key injectable plant Unit 4 in Hyderabad.