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Agency moves forward with charges against Advanced Bionics

This article was originally published in The Gray Sheet

Executive Summary

FDA continues to pursue civil money penalties totaling $2.2 million against cochlear implant maker Advanced Bionics and CEO Jeff Greiner, although the agency has dropped a previous $1.1 million charge against co-CEO Al Mann and added "some" GMP charges, according to an FDA spokeswoman. The suit, which was originally filed in November 2007 and amended March 17, alleges manufacturing standard violations and failure to notify the FDA of a change in an outside supplier or vendor, which may have exposed device recipients to unnecessary health risks. The company previously indicated it hopes to settle the case before it goes before an administrative judge (1"The Gray Sheet" Feb. 4, 2008, p. 7)
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