Zydus gets USFDA's Establishment Inspection Report for Vadodara facility

Zydus Lifesciences Ltd. informed the exchanges on Tuesday, June 10, that the company has received the Establishment Inspection Report (EIR) report from the US Food and Drug Administration (FDA) for the inspection conducted at its API manufacturing facility located at Dabhasa near Vadodara.

This facility underwent an inspection from April 21 to April 25, 2025, and has been classified as Voluntary Action Indicated (VAI). FDA confirmed the inspection as "closed".

What is EIR

These classifications are generally communicated in the EIR but sometimes the EIRs may not contain the classification either. It is important to clarify that the EIR is essentially a document which is issued with a lag after a plant inspection has taken place by the USFDA. Issuance of an EIR does not mean the plant is cleared.

Generally, if a plant already has an outstanding warning letter or import alert on the facility and is issued a more benign classification such as NAI or VAI then it is likely that the earlier regulatory action will also eventually be reversed or lifted, however, it needs to be communicated explicitly. Similarly, an OAI with an already outstanding warning letter or import alert could mean further bad news for the company.

Shares of Zydus Lifesciences Ltd. are trading with gains of 0.41% on Tuesday at ₹977.60.