USFDA gives Voluntary Action Indicated (VAI) classification to Sun Pharma’s Dadra plant

The health regulator had inspected the company’s Dadra facility from March 22 – March 29, 2019; and at the conclusion of the inspection, had issued a Form 483, with 11 observations to the company

The United States Food and Drug Administration (USFDA) has given voluntary action indicated classification to drug major Sun Pharmaceutical Industries for its Dadra plant.

The health regulator had inspected the company’s Dadra facility from March 22 – March 29, 2019; and at the conclusion of the inspection, had issued a Form 483, with 11 observations to the company.

In a notification on its website, USFDA has given Voluntary Action Indicated (VAI) classification to the Dadra inspection.

As per the USFDA, VAI means that though “objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action”.

In a regulatory filing in April, Sun Pharma had said that it had submitted response to the USFDA within the stipulated timeline and it was committed to addressing the observations promptly.

One of the observations by the USFDA related to employees engaged in manufacturing, processing, packaging and holding of a drug product were lacking education, training and experience required to perform their assigned functions.