Warning Letter Roundup & Recap – August 25, 2015
This article was originally published in The Gray Sheet
Maker of the Crono S-PID-50 infusion pump cited for quality system deficiencies, including failing to investigate 26 maintenance reports that included complaints; a contract sterilizer didn't validate the sterilization of disposable tubing sets used with Euromi's EVA Sp6 device; and more. Four device warning letters were listed by FDA this week.
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