USFDA classifies Biocon Biologics Johor Bahru site, Malaysia as VAI

Biocon Biologics remains committed to global standards of quality and compliance

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 had 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.

Biocon Biologics remains committed to global standards of quality and compliance.