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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