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The U.S. FDA classified Biocon Biologics’ Johor Bahru insulin facilities as Voluntary Action Indicated (VAI) after inspecting multiple biologics manufacturing and quality control units in September 2024.
Biocon Biologics’ insulin manufacturing facilities in Johor Bahru, Malaysia, have been classified as Voluntary Action Indicated (VAI) by the U.S. Food and Drug Administration (FDA). The classification follows a comprehensive cGMP inspection conducted between 15 and 27 September 2024. The inspection covered multiple biologics manufacturing units, including a Drug Substance unit, Drug Product unit, Medical Device Assembly unit, Analytical Quality Control Laboratory, two Microbiological Control Laboratories, and two Warehouses.
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FDA conducted a cGMP inspection of Biocon Biologics facilities in September 2024.
Inspection scope included eight manufacturing and quality control units.
Facilities classified as Voluntary Action Indicated (VAI).
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The FDA’s inspection included a thorough evaluation of Biocon Biologics’ key manufacturing and quality control facilities.
Unit Inspected | Function |
Drug Substance Unit | Produces active ingredients for insulin |
Drug Product Unit | Manufactures final insulin formulations |
Medical Device Assembly Unit | Assembles insulin delivery devices |
Analytical Quality Control Laboratory | Ensures product quality and compliance |
Microbiological Control Laboratories | Conduct microbiological testing |
Warehouses | Store raw materials and finished products |
The VAI classification indicates that while certain observations were made, no critical violations requiring mandatory action were identified. This recognition further solidifies Biocon Biologics’ commitment to maintaining global quality and compliance standards.
The FDA’s VAI classification for Biocon Biologics’ Johor Bahru facilities reflects the company’s consistent adherence to cGMP guidelines. This development may positively influence the Biocon Biologics share price as the company continues its focus on quality manufacturing for global markets.
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