# FDA 483 - Advanced Bionics, LLC - September 28, 2018

Source: https://www.keypedia.com/records/483/advanced-bionics-llc/51cb9635-2331-4dfa-96d5-8333a7cb3b68

> FDA 483 for Advanced Bionics, LLC on September 28, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Advanced Bionics, LLC
- Inspection Date: 2018-09-28
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Advanced Bionics, LLC, a medical device manufacturer in Valencia, CA, received two observations during an FDA inspection. The firm was cited for inadequate documentation of design verification results, specifically lacking source data for mechanical impact performance. Additionally, the inspection revealed a failure to adequately control non-conforming products, leading to their re-entry into production after initial quarantine.

## Related Officers

- [Kelvin Cheung](https://www.keypedia.com/people/kelvin-cheung/ded61aee-4b4b-4049-a67c-19d971475be7)

Company: https://www.keypedia.com/companies/advanced-bionics-llc/30205082-5b11-422f-a4e0-743599be76c4

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