Torrent Pharmaceutical's Dahej plant receives VAI classification from the USFDA

The manufacturing facility of Torrent Pharmaceutical in Dahej, Gujarat, has been classified as Voluntary Action Indicated by the USFDA.

A VAI classification indicates that objectionable conditions or practices have been found, but the agency is not prepared to take or suggest administrative or regulatory action.

According to its website, the United States Food and Drug Administration (USFDA) has classified the plant as Voluntary Action Indicated (VAI).

The Dahej facility was previously classified as 'Official Action Indicated (OAI)' based on the results of an inspection in March 2019. During inspections, OAI signifies "objectionable conditions were found and regulatory administrative sanctions by FDA are indicated."

The USFDA re-inspected the Dahej site between May 17 and May 25, 2023, and issued Form 483 with two observations.

At the completion of an inspection, Form 483 is sent to the firm's management if the investigator observes any situations that, in its opinion, may constitute violations of the Food, Drug, and Cosmetic (FD&C) Act and related Acts.

The VAI classification of the Dahej manufacturing plant would be a huge relief for the drug manufacturer, which produces active pharmaceutical ingredients and formulations at the facility. According to the categorization, the company will now be able to get approval for any pending ANDAs (Abbreviated New Drug Applications) through the site.

Source: Media Reports