US FDA classifies Biocon Biologics site as VAI

The US Food and Drug Administration (FDA) has classified Biocon Biologics’ Insulins facilities in Johor Bahru, Malaysia as Voluntary Action Indicated (VAI). 

This relates to the cGMP inspection conducted by the agency between September 15 – 27, 2024. The inspection scope included several biologics manufacturing units comprising one Drug Substance and one Drug Product manufacturing units, one Medical Device Assembly unit, one Analytical Quality Control Laboratory, two Microbiological Control Laboratories and two Warehouses.