USFDA issues EIR for Zydus Jarod injectable facility
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-12-04 07:44 GMT | Update On 2025-12-04 07:44 GMT
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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
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.
Read also: Zydus Lifesciences bags USFDA approval for advanced prostatic cancer injection
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