Institute of Good Manufacturing Practices India®

Reopening of investigation by USFDA of unit 4 facility of Aurobindo


Reopening of investigation of Aurobindo Pharma’s Unit-4 manufacturing facility by the US Food and Drug Administration, days after the regulator had declared that it had suggested voluntary action by the company to follow good manufacturing practices.

Aurobindo in a statement to the stock exchanges on Friday commented that it has been furnished with a communication from USFDA that the inspection was done by the regulator from November 4 to 13, 2019, is still open and under review by way of “rescindment of 90-day voluntary action indicated (VAI) letter that was furnished to the company on February 18, 2020”.

The revocation of VAI seems almost like a warning letter, stated by Surjit Pal an analyst from brokerage firm Prabhudas Lilladher (PL).

This proofs that the USFDA is unlikely to give grants to pending ANDAs (abbreviated new drug applications), or applications for generic drug licences in the US, from the injectable plant in Hyderabad without resolving to the investigation.