US FDA revokes EIR issued to Aurobindo Pharma's Unit IV facility

On February 18, the US FDA issued the EIR with voluntary action indicated for Aurobindo Pharma's Unit IV injectable formulations unit

The US Food and Drug Administration (US FDA) on Friday revoked the Establishment Inspection Report(EIR) issued on February 18 for Aurobindo Pharma Limited's Unit IV injectable formulations unit.

An EIR by the US drug regulator would mean that the inspection of a particular manufacturing facility was concluded without the need to issue any inspectional observations since the manufacturing facility was found to be broadly compliant with the regulations.

On February 18, the US FDA issued the EIR with voluntary action indicated (VAI) for Unit IV. The VAI would mean that the US FDA had found some objectionable conditions but they