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BRIEF-RTI Surgical receives warning letter from FDA
November 14, 2017 / 1:30 PM / 4 days ago

BRIEF-RTI Surgical receives warning letter from FDA

Nov 14 (Reuters) - RTI Surgical Inc

* On Nov 9, co received a warning letter from FDA resulting from an inspection of co’s facility in Alachua, Florida in April

* Warning letter relates to processes used in manufacture of map3 cellular allogeneic bone graft product ​

* Warning letter also relates to FDA’s views with respect to map3 allograft’s regulatory classification​

* Warning letter does not restrict production, marketing, or distribution of map3 allograft​

* Intends to conduct clinical studies that further confirm safety and efficacy of map3(reg) allograft​ Source text for Eikon: (bit.ly/2idYURl) Further company coverage:

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