Zydus Lifesciences has received the Establishment Inspection Report (EIR) from the USFDA for its oncology injectable manufacturing facility in SEZ1, Ahmedabad. The inspection, conducted from June 9th to 18th, 2025, resulted in the facility being classified as Voluntary Action Indicated (VAI). This is a revision from the previous classification of Official Action Indicated (OAI) in June 2024.
USFDA Inspection Outcome
Zydus Lifesciences announced that its oncology injectable manufacturing facility located in SEZ1, Ahmedabad, has received an Establishment Inspection Report (EIR) from the USFDA. This follows a GMP follow-up inspection that occurred between June 9th and June 18th, 2025.
Voluntary Action Indicated
The USFDA has classified the facility as Voluntary Action Indicated (VAI). This new classification revises an earlier classification in June 2024. Previously, the facility was classified as Official Action Indicated (OAI), however it now falls under the VAI category.
Source: BSE
