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 did not warrant any regulatory action.

But, the US drug regulator sent another letter to the company on February 21 correcting its earlier position on the outcome of the inspection. "Received a further communication that inspection conducted by the US FDA at our aforesaid Unit IV from November 4 to November 13, 2019 is still open and under review by way of rescindment of 90-day VAI letter that was issued by them on February 18, 2020," the company informed the stock exchanges.

On February 18, Aurobindo Pharma's stock jumped as much as 19 per cent in early trade following the news of USFDA's previous letter.