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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