USFDA rescinds VAI status for Aurobindo Pharma's Hyderabad unit

Drug firm Aurobindo Pharma on Friday said the US health regulator has revoked the voluntary action initiated (VAI) status for its Unit-IV facility in Hyderabad.

The company has received a communication that the inspection conducted by the US Food and Drug Administration (USFDA) at our Unit IV, from November 4 to 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 filing to BSE.

The USFDA had in earlier in November 2019 issued a Form 483 with 14 observations after the inspection of Aurobindo Pharma's Unit-IV, a general injectable formulation manufacturing facility.