India Pharma Outlook Team | Wednesday, 15 February 2023
Aurobindo Pharma said it has received Voluntary Action Indicated (VAI) from the US health regulator for its Telangana-based manufacturing plant. As per the information available on the United States Food and Drug Administration (USFDA) website, the company's Unit - IX, an API intermediate facility situated at Sangareddy District, Telangana, has now been classified as Voluntary Action Indicated (VAI), the drug maker said in a regulatory filing.
The USFDA had inspected the site from November 10 to November 18, 2022. As per the USFDA, a VAI means that objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.