The Dahej facility of Torrent Pharmaceutical receives VAI classification from the USFDA

24 Aug 2023 , 11:03 AM

The production facility for Torrent Pharmaceuticals in Dahej, Gujarat, has been classified as Voluntary Action Indicated by the US health authorities.

If you receive a VAI classification, it signifies that although the agency has uncovered undesirable conditions or practices, it is not yet ready to take or suggest any administrative or regulatory action.

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

Based on the findings of an inspection conducted in March 2019, the Dahej facility was previously given the label ‘Official Action Indicated (OAI)’. OAI stands for ‘objectionable conditions were found and regulatory administrative sanctions by FDA are indicated’ in the context of inspections.

Between May 17 and May 25, 2023, the USFDA conducted a second inspection of the Dahej location and issued a Form 483 with two observations.

When the investigator finds any conditions that, in its opinion, may constitute breaches of the Food, Drug, and Cosmetic (FD&C) Act and related Acts, Form 483 is given to the management of the firm.

For the pharmaceutical company, which uses the Dahej factory to make active medicinal components and formulations, the VAI certification would be a huge relief. According to the classification, the business will be able to obtain approval for all pending ANDAs (Abbreviated New Drug Applications) from the website going forward.

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