Warning Letter Roundup & Recap – September 1, 2015
This article was originally published in The Gray Sheet
Cardiac monitor manufacturer Cardiac Designs didn't have an adequate system for receiving and evaluating complaints forwarded to the firm from a third-party complaint handling company; marketer of the WaveLight EX500 Excimer Laser System – used in LASIK procedures – was cited for premarket reg violations; and more. Four device warning letters were listed by FDA this week.
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