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FDA Warning Letters – March 24, 2015

This article was originally published in The Gray Sheet

Executive Summary

Failure to gain clearance or approval was the main focus of the two device-related warning letters posted by the agency on March 24. FDA says Zizion Group is selling its blood platelet-rich plasma prep kits without any clearance or approval and that Tiller Mind Body modified its colon irrigation system without regulatory go-ahead

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