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FIRST US FDA Inspection

Between September 22nd and September 24th, 2008, FDA inspectors conduct on-site inspection of NOVAST's current Good Manufacturing Practices (CGMP) facilities and management systems; this inspection includes data verification of the first submitted product. In November 2009, the US FDA issues a formal letter stating that the US FDA has completed internal reviews of the inspection report (EIR), concluding that NOVAST CGMP facilities and management systems meet US FDA requirements. This is the first time that  NOVAST has been successfully inspected by the US FDA. Success on this inspection marks the beginning at a new stage of development for NOVAST.