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

Source: https://www.globalkeysolutions.net/records/483/advance-bionics-corp-llc/390fe577-d4bb-4263-ba93-41a6a22cd40b

> FDA 483 for Advance Bionics Corp. L.L.C. on February 27, 2008. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Advance Bionics Corp. L.L.C.
- Inspection Date: 2008-02-27
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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.

## Related Officers

- [William F. Regnault](https://www.globalkeysolutions.net/people/william-f-regnault/f7c7e29e-66b4-428c-bded-6c0815a837a4)
- [company_representative](https://www.globalkeysolutions.net/people/james-kang/0cb322d3-dc64-46cb-a6bc-28efa33e94af)
- [Norman Wong](https://www.globalkeysolutions.net/people/norman-wong/d97335f2-571c-4a83-ba9b-893ce0c05b0d)
- [James R. Fleckenstein](https://www.globalkeysolutions.net/people/james-r-fleckenstein/898bcb95-fc85-4397-ac7f-cb580c9a373d)

Company: https://www.globalkeysolutions.net/companies/advance-bionics-corp-llc/533fb89c-683a-41e6-9d54-19c8f5a46802

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6