Warning Letter Roundup & Recap – June 2, 2015
This article was originally published in The Gray Sheet
Employees tasked with reviewing quality audits at Soft Computer Consultants weren't trained on the current version of the firm's audit approval procedure; maker of intra-aortic balloon catheters and inguinal hernia implants cited for QS and MDR reg violations; and more. Four device warning letters were listed by FDA this week.
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