(FDA: Rockville, Maryland) -- The U.S. Food and Drug Administration is seeking a $2.2 million penalty against a California hearing device manufacturer, Advanced Bionics LLC and its president and co-CEO, Jeffrey H. Greiner, for violations of federal law, including manufacturing standards violations and the failure to notify the FDA of a change in an outside supplier or vendor, which may have exposed recipients of the devices to unnecessary health risks.

The complaint alleges that the company failed to comply with the FDA’s current good manufacturing practice (GMP) requirements for devices. GMP requires that companies manufacturing medical devices for sale in the United States establish and follow quality systems procedures to ensure the safety and quality of their products.

Advanced Bionic’s alleged GMP violations include 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 cochlear implant by testing lots under actual or simulated use when the unapproved vendor’s component was used.

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