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Warning Letter Roundup & Recap – October 13, 2015

This article was originally published in The Gray Sheet

Executive Summary

An FDA investigator observed two different products with the same lot number at a manufacturer of cannulas and trocars; employees at Lusys Labs – a maker of in vitro diagnostic kits – handled and packaged coated membranes with bare hands; procedures at software-maker Merge Healthcare allowed for devices that hadn't fully completed design validation to be shipped to end users for clinical use on patients; and more. Six device warning letters were listed by FDA this week.

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