The U.S. Food and Drug Administration (FDA) CDER-OC, Office of Manufacturing Quality, has classified Biocon Biologics' Drug Substance Facility at Biocon Campus, located in Bengaluru, Karnataka, as Voluntary Action Indicated (VAI).

This relates to the inspection conducted by the agency between August 26 to September 3, 2025, and pertains to the manufacture and supply of Human Recombinant Insulin (rh- Insulin) and Biosimilar Pegfilgrastim Drug Substance to the United States.