Biocon Update: U.S. FDA classifies Johor Bahru facility as VAI

Biocon Limited has announced that the U.S. Food and Drug Administration (FDA) has classified its biologics manufacturing site in Johor Bahru, Malaysia, as “Voluntary Action Indicated” (VAI). This decision follows a cGMP inspection conducted by the FDA between September 15 and September 27, 2024.

Key Highlights:

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  • Inspection Scope: The FDA inspection covered multiple manufacturing and quality control units, including:
    • One Drug Substance Unit
    • One Drug Product Manufacturing Unit
    • One Medical Device Assembly Unit
    • One Analytical Quality Control Laboratory
    • Two Microbiological Control Laboratories
    • Two Warehouses
  • Outcome: The VAI classification indicates that while there were observations during the inspection, they are not significant enough to merit regulatory or enforcement actions.
  • Commitment to Compliance: Biocon Biologics reaffirmed its dedication to adhering to global quality and compliance standards, emphasizing its commitment to producing safe and effective biologics.