Epic Update : Fresenius Kabi

Receives warning letter from US FDA for API plant at Kalyani, India
Warnings related to Good Manufacturing Practices (GMP) non-conformities regarding manufacturing
US FDA warnings related to documentation practices
US FDA warnings related to data integrity
Will respond comprehensively to the warning letter
’13 guidance incl expected 1-time charge to remediate issue. - See more at: http://www.epicresearch.co/blog/#sthash.teHjOhqu.dpuf

Receives warning letter from US FDA for API plant at Kalyani, India
Warnings related to Good Manufacturing Practices (GMP) non-conformities regarding manufacturing
US FDA warnings related to documentation practices
US FDA warnings related to data integrity
Will respond comprehensively to the warning letter
’13 guidance incl expected 1-time charge to remediate issue.   

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