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FDA Seeking Civil Damages from CA Firm

FDA announced it is seeking $2.2 million in damages from Advanced Bionics, LLC and its president for various violations of federal law. The violations against the cochlear implant hearing aid manufacturer include failure to follow Good Manufacturing Practices and shipping affected hearing aids after a recall.

Specifically, FDA cited the failure to sufficiently evaluate and select a new vendor as the supplier of a critical device component, and the failure to adequately validate the continued safety and effectiveness of the hearing aid by testing lots under actual or simulated use when the unapproved vendor's component was used. The failure was first noted at a 2001 inspection.

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