Zydus Lifesciences gets FDA EIR with VAI for Moraiya formulations plant

Zydus Lifesciences said that the US Food and Drug Administration (FDA) has issued an establishment inspection report (EIR) for its Moraiya formulations manufacturing plant near Ahmedabad, Gujarat.

According to the Indian pharma company, the American drug regulator concluded that the inspection classification of the formulations manufacturing facility is voluntary action indicated (VAI).

Zydus Lifesciences gets FDA EIR with VAI for Moraiya formulations plant. Photo courtesy of Zydus Cadila.

Zydus Lifesciences stated the FDA inspected its Moraiya factory from 26 July to 5 August 2022 which resulted in four observations. The regulator has indicated that it has closed the inspection of the formulations manufacturing plant, said Zydus Lifesciences.