# FDA 483 - Advanced Bionics, LLC - September 15, 2004

Source: https://www.globalkeysolutions.net/records/483/advanced-bionics-llc/475861db-d1dd-4b69-9037-8679c03fb58e

> FDA 483 for Advanced Bionics, LLC on September 15, 2004. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Advanced Bionics, LLC
- Inspection Date: 2004-09-15
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Advanced Bionics Corporation revealed significant quality system deficiencies, primarily concerning moisture entrapment in hermetically sealed cochlear implants, leading to device failures. The firm failed to adequately report these issues to the FDA, conduct proper management reviews, establish effective design and process validations, and implement robust corrective and preventive actions. These systemic problems expose patients to risks of device failure and surgical intervention.

## Related Officers

- [JAMES R. KONE, Audiologist](https://www.globalkeysolutions.net/people/james-r-kone-audiologist/23516a0a-84de-42e3-99b2-47e584e47fbc)
- [William F. Regnault, Supervisory Engineer](https://www.globalkeysolutions.net/people/william-f-regnault-supervisory-engineer/2d0b8dbc-6402-4cfc-a094-62c1d8d8a2a7)
- [James R. Fleckenstein](https://www.globalkeysolutions.net/people/james-r-fleckenstein/898bcb95-fc85-4397-ac7f-cb580c9a373d)
- [Investigative Engineer ](https://www.globalkeysolutions.net/people/leonard-h-lavi/afe5082f-67e5-4bf2-a981-022756e93eb4)
- [Norman Wong](https://www.globalkeysolutions.net/people/norman-wong/d97335f2-571c-4a83-ba9b-893ce0c05b0d)

Company: https://www.globalkeysolutions.net/companies/advanced-bionics-llc/a85a3594-768e-4f01-a859-ee4a874576fe

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