Institute of Good Manufacturing Practices India®

USFDA retracted status of VAI for Unit-IV plant of Aurobindo Pharma


The US Food and Drug Administration (FDA) revoked the status of ‘Voluntary Action Initiated’ (VAI) furnished to Unit-IV plant of Aurobindo Pharma in Hyderabad.

Aurobindo Pharma stated that it has achieved further communication from the USFDA on its Unit IV injectable plant commenting that the evaluation is still open and under review by way of rescindment of 90-day VAl letter that was furnished by them on February 18, 2020.

Aurobindo Pharma stated that the letter issued on February 19, stated that the establishment inspection report (EIR) with voluntary action indicated (VAI) categorization for the facility was erroneously sent to the company and is being revoked.