Biocon Biologics Bengaluru drug substance facility classified as VAI
Bengaluru: Biocon has announced that the U.S. Food and Drug Administration (USFDA) has classified Biocon Biologics' Drug Substance Facility at Biocon Campus, (Site 1) located in Bengaluru, Karnataka, as Voluntary Action Indicated (VAI).
Voluntary action indicated means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
This relates to the cGMP inspection conducted by the agency between February 20- 28, 2024 and pertains to the supply of rh-Insulin (rhI) Drug Substance to the United States.
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"Biocon Biologics remains committed to global standards of Quality and Compliance,” the Company stated.
Medical Dialogues team had earlier reported that the US FDA had concluded a surveillance inspection with four observations at the Biocon's API facility (Site 2), located at Bengaluru, Karnataka.
Biocon Limited, publicly listed in 2004, is an innovation-led, 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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