USFDA issues EIR for Zydus Jarod injectable facility
Ahmedabad: Zydus has announced that the company has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) for a GMP follow-up inspection at its injectable facility located at Jarod, Vadodara.
The inspection took place from August 25 to September 5, 2025. Initially, the facility received four observations from the USFDA.
The facility has now been classified as Voluntary Action Indicated (VAI), which means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
This inspection followed a Warning Letter issued by the USFDA on August 29, 2024, which summarized violations with respect to Current Good Manufacturing Practice (cGMP) regulations. Notably, the Warning Letter did not contain any data integrity related violations.
Zydus Lifesciences Ltd. is a global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. Over the last decade, Zydus has introduced several products in the market for treating unmet healthcare needs with vaccines, therapeutics, biologicals and New Chemical Entities.
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