23-item 483 handed to Advanced Bionics, citing MDRs, training, process validation, risk analysis.(MEDICAL DEVICES)

From: Inspection Monitor | Date: July 1, 2005 | Copyright information

Advanced Bionics Corporation, Sylmar, CA, Irvine, CA, District

An incomplete Medical Device Report (MDR), inadequate employee training, a process that was not re-validated following deviations, and incomplete risk analysis were highlights of a 23-item 483 for medical device manufacturer Advanced Bionics Corporation, Irvine, CA.

The company's website stated that the firm is a developer of implantable neurostimulation devices that help to treat deafness and chro...

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