A VAI classification indicates that unacceptable conditions or practices were discovered, but the agency isn’t prepared to recommend or take any regulatory or administrative decision.
The US health department has given Voluntary Intervention Indicated classification to the manufacturing facility of Torrent Pharmaceutical located in Dahej, Gujarat.
A VAI classification indicates that the existence of objectionable practices or conditions were identified, however the agency isn’t willing to take or recommend any regulatory or administrative measure.
According to the information that is available on their website, the United States Food and Drug Administration (USFDA) has granted Voluntary Action Indicated (VAI) classification to the plant.
Dahej site was previously classified as a ‘Official Action Indicated’ Dahej site was previously placed under the ‘Official Action Indicated (OAI) the classification in March 2019, based on an inspection report.
OAI refers to “objectionable conditions were found and regulatory administrative sanctions by FDA are indicated” in the course of inspections.
Dahej site was re-inspected by the USFDA. Dahej site was again inspected through officials from the USFDA from May 17 between May 25 and May 25th, 2023, and the authorities had issued Form 483 with two observations.
Form 483 is sent to a company’s management after the end of an inspection, if the inspector has found any issues that could constitute a violation that are in violation of Food Drug and Cosmetic (FD&C) Act as well as related Acts.
It is believed that the VAI designation for the Dahej plant will be an immense relief for the drug company that produces pharmaceutical active ingredients and formulations on the plant. This classification means that the company is in a position to obtain approval for all of its pending ANDAs (Abbreviated NEW Drug Applications) from the site.