USFDA inspection: Zydus gets EIR for Dabhasa API manufacturing facility
Ahmedabad: Zydus has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for the inspection conducted at its API manufacturing facility located at Dabhasa near Vadodara.
This facility underwent an inspection from 21st to 25th April 2025 and has been classified as Voluntary Action Indicated (VAI). VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action
FDA confirmed the inspection as “closed”.
Earlier in April, the USFDA had issued six observations for the group’s API Unit, located at Dabhasa in Gujarat.
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Zydus Lifesciences Ltd. is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs 27,000 people worldwide, including 1,400 scientists engaged in R & D. Over the last decade, Zydus has introduced several innovative, first-in-class products in the market for treating unmet healthcare needs with vaccines, therapeutics, biologicals and biosimilars.
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