Regulatory Open Forum

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  • 1.  Site inspection question

    Posted 17-May-2016 17:20

    Hello All,

    After a drug manufacturing site has been inspected and later the site wants to manufacture a different drug, must the site be inspected again?

    Thanks,

    Sarah

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    Sarah Green
    Cyclomedical International Inc.
    Knoxville TN
    United States
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  • 2.  RE: Site inspection question

    Posted 18-May-2016 03:44
    That is entirely at the discretion of the regulatory authorities
     
    Regards
    Siegfried
     
     
     



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