Biocon Biologics has recently informed exchanges that the US Food and Drug Administration (FDA) has classified its Drug Substance Facility at the Biocon Campus in Bengaluru as Voluntary Action Indicated (VAI).
This update follows a detailed inspection carried out by the FDA’s Center for Drug Evaluation and Research – Office of Compliance (CDER-OC), Office of Manufacturing Quality, between August 26 and September 3, 2025.
The inspection focused on the company’s manufacturing and supply processes for Human Recombinant Insulin (rh-Insulin) and Biosimilar Pegfilgrastim Drug Substance, both of which are supplied to the United States market.
Receiving a VAI classification indicates that the FDA has found certain issues that require voluntary corrective actions, but nothing significant enough to restrict product approvals or market supply. In regulatory terms, VAI is generally seen as a positive outcome, as it reflects an acceptable level of compliance with US quality standards.
