US FDA clears Aurobindo Pharma Unit IV, reverts classification to VAI

Topics USFDA | Aurobindo Pharma

Aurobindo Pharma | Photo: Wikipedia
The US Food and Drug Administration(US FDA) has reverted its inspection classification of Aurobindo Pharma Limited's Unit IV back to voluntary action indicated(VAI), relieving the company of any further regulatory action for this manufacturing facility.

The US FDA had n February 21 told Aurobindo that the inspection conducted at Unit IV from November 4-13, 2019 was still open and under review by way of rescindment of 90-day VAI letter that was issued by the drug regulator just a couple of days before.

On February 19 the drug regulator had issued the Establishment Inspection Report(EIR) with voluntary action for the same plant, clearing the manufacturing facility from further regulatory action. Two days later it revoked the EIR.

The latest classification, VAI, suggests that though certain objectionable conditions were found during the review, they did not warrant any further regulatory action. The company's stock price jumped as much as 15 per cent on Bombay Stock Exchange in the morning trade on Tuesday.


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