Zydus Lifesciences gets USFDA EIR for Moraiya facility

Ahmedabad: Global Lifesciences company, Zydus Lifesciences Ltd., today announced the receipt of an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its formulations manufacturing facility in Moraiya, near Ahmedabad, India.

The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI).

Voluntary Action Indicated (VAI) means objectionable conditions or practices were found but the agency is not prepared to take or recommend any administrative or regulatory action.

The USFDA had inspected the facility from 26th July to 5th August, 2022 which concluded with four observations. The USFDA has indicated that the inspection is closed.

Read also: Zydus Ahmedabad facility gets 4 USFDA observations

Zydus Lifesciences Limited, formerly known as Cadila Healthcare Limited, is an Indian multinational pharmaceutical company headquartered in Ahmedabad. The company is primarily engaged in the manufacture of generic drugs. Zydus group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim in India and in the US and Brazil.