Zydus Lifesciences Receives USFDA EIR for Jarod, Vadodara Plant

The Establishment Inspection Report (EIR) issued to Zydus Lifesciences by the U.S. Food and Drug Administration (USFDA) concerning the GMP follow-up inspection at its injectable manufacturing facility in Jarod, Vadodara. This audit was carried out between 25 August-05 September 2025 and the centre had been identified as Voluntary Action Indicated (VAI). This follows a Warning Letter that was issued by the USFDA on 29 August 2024.

According to the VAI classification, the facility does not need any additional regulatory measures at the time, which is a significant milestone in the process of enhancing compliance within the facility, which Zydus should achieve. The receipt of EIR offers the basis for when the follow-up inspection is being performed and that the agency has finished reviewing the corrective measures taken by the company.

Also Read: India's Hospitals Face Rising Risk of U.S.-Style Fee-for-Service

Jarod injectable plant is another important component of the manufacturing network of Zydus Lifesciences and it provides products to controlled markets abroad. The recent regulatory communication enables the firm to proceed with a more stable business operation and, at the same time, advance the quality and compliance systems in the manufacturing activities.

The USFDA follow-up review and the previous regulatory inspections have been observed to be aspects that Zydus Lifesciences has been undertaking in its efforts to ensure compliance, which is a continuous process. The EIR and VAI classification will facilitate the work of the company, which consists of keeping consistent production and having the availability of the injectable portfolio to offer to the global markets.