Biocon Biologics’ Bengaluru unit gets VAI classification by US FDA

Biocon Biologics announces that its drug substance facility located at Biocon Campus, (Site 1) Bengaluru, has been classified as voluntary action indicated by the US Food and Drug Administration. 

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.

Under voluntary action indicated (VAI), while objectionable conditions were found and documented during an inspection, the agency is not prepared to take or recommend regulatory action, as per the US FDA.