Advanced Bionics Requests Extra Time To Answer Amended FDA Complaint
This article was originally published in The Gray Sheet
Executive Summary
Cochlear implant maker Advanced Bionics and CEO Jeff Greiner requested extra time April 15 to respond to FDA's amended administrative complaint against the firm, which adds three quality systems violation allegations to the original suit
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Advanced Bionics/FDA settlement
Cochlear implant maker settles July 14 with FDA over allegations filed in late 2007 that the firm did not properly submit a PMA supplement when it added a vendor for a component of its HiRes90K device and violated quality system regulations (1"The Gray Sheet" April 21, 2008, p. 15). Advanced Bionics will pay FDA a civil money penalty of $1.1 million and CEO Jeff Greiner will pay $75,000 (down from $1.1 million previously sought). Neither the firm nor Greiner admits liability under the agreement
Advanced Bionics/FDA settlement
Cochlear implant maker settles July 14 with FDA over allegations filed in late 2007 that the firm did not properly submit a PMA supplement when it added a vendor for a component of its HiRes90K device and violated quality system regulations (1"The Gray Sheet" April 21, 2008, p. 15). Advanced Bionics will pay FDA a civil money penalty of $1.1 million and CEO Jeff Greiner will pay $75,000 (down from $1.1 million previously sought). Neither the firm nor Greiner admits liability under the agreement
FDA Seeks Fines From Advanced Bionics And Execs For Not Filing Supplement
FDA is pursuing Advanced Bionics and its two co-CEOs for $1.1 million each in fines, alleging that the company did not file a PMA supplement for adding a vendor for a component of its cochlear implant