FDA Inspection History

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  November 2008, FDA audit of USA site: no 483 observations

  August 2011, FDA audit of USA site: no 483 observations

  October 2011, sFDA audit of Shanghai site: no observations

  March 2013, FDA PAI of USA site: 4 “483” observations

  August 2013, FDA PAI of Shanghai site: 2 “483” observations

  October 2014, FDA PAI of US site: 1 ‘483’ observation

  January 2016, FDA audit of Shanghai site: no ‘483’ observations

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