FDA revokes VAI status for Aurobindo Pharma's Hyd unit

Hyderabad: 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.