USFDA issues EIR for Biocon Generics Cranbury facility
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-12-19 06:00 GMT | Update On 2025-12-19 06:00 GMT
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Bengaluru: Biocon has announced that the Company has received an Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) status from the U.S. Food and Drug Administration (US FDA), for its Biocon Generics Inc facility, located in Cranbury, New Jersey, U.S.
This is based on a cGMP inspection conducted by the agency between the 6th to 10th of October, 2025.
VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
Biocon Limited, publicly listed in 2004, is a global biopharmaceutical company. It has developed and commercialized novel biologics, biosimilars and complex small molecule APIs in India and several key global markets, as well as generic formulations in the US and Europe.
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