BRIEF-RTI Surgical receives warning letter from FDA | Reuters

Reuters| Tue Nov 14 04:43:42 EST 2017
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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