US FDA Ends Zydus Lifesciences’ Dabhasa Plant inspection With VAI tag

Zydus Lifesciences Ltd. on Tuesday said the US Food and Drug Administration has concluded its inspection at the company’s active pharmaceutical ingredients manufacturing plant in Dabhasa, near Vadodara, Gujarat.

The audit was carried out between April 21 and April 25, and the US drug regulator issued an Establishment Inspection Report with a Voluntary Action Indicated status.

This means that while some objectionable conditions were found during the inspection, the regulator will not initiate any administrative or regulatory action. However, the company has been advised to address the issues voluntarily.