USFDA issues EIR for Biocon Bengaluru facility
Bengaluru: Biocon 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 API facility (Site 1), located at Bengaluru, Karnataka. The inspection stands closed as per 21 CFR20.64(d)(3).
Voluntary action indicated (VAI) means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action
This is based on a surveillance inspection conducted by the agency between the 16th to 20th of September, 2024.
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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