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:
- 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.
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Biocon