FDA 483 - Advance Bionics Corp. L.L.C. - February 27, 2008

An FDA inspection of Advance Bionics Corp. L.L.C. in Valencia, CA, revealed significant deficiencies in their quality system, particularly concerning their HiRes 90K cochlear implants. The firm failed to adequately investigate nonconformities, develop necessary diagnostic procedures for failing devices, and properly validate processes. Additionally, the company did not submit an MDR report for a serious adverse event involving meningitis, despite prior FDA guidance.