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Warning Letter Roundup & Recap – August 18, 2015

This article was originally published in The Gray Sheet

Executive Summary

Two duodenoscope manufacturers – Fujifilm and Hoya and Olympus – receive scathing letters from FDA targeting problems at multiple facilities in Japan and the U.S., while a third is dinged for adverse event reporting troubles; maker of Accusorb MRI radiofrequency-shielding devices cited for QS, MDR, premarket and product recall violations; and more. Six device warning letters were listed by FDA this week.


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