USFDA rescinds VAI status for Aurobindo Pharma’s Hyderabad unit

PTI w Delhi | Updated on February 21, 2020 Published on February 21, 2020

Ne 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 rescinding the 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 November 2019, issued a Form 483 with 14 observations after the inspection of Aurobindo Pharma’s Unit-IV, a general injectable formulation manufacturing facility.

Published on February 21, 2020
This article is closed for comments.
Please Email the Editor