USFDA reopens investigation of Aurobindo’s unit 4 facility

The US Food and Drug Administration has reopened its investigation of Aurobindo Pharma’s Unit-4 manufacturing facility, days after the regulator had announced that it had recommended voluntary action by the company to follow good manufacturing practices.
The company has received a communication from USFDA that the inspection completed by the regulator from November 4 to 13, 2019, is still open and under review by way of rescindment of 90-day voluntary action indicated (VAI) letter that was issued to the company on February 18, 2020.
The revocation of VAI seems almost like a warning letter.
This means the USFDA is unlikely to give approvals to pending ANDAs (abbreviated new drug applications), or applications for generic drug licenses in the US, from the injectable plant in Hyderabad without resolution to the investigation.