# FDA 483 - Neodontics Inc - January 24, 2023

Source: https://www.keypedia.com/records/483/neodontics-inc/26cfd4a7-6279-4fc7-8d52-a9c304e6352b

> FDA 483 for Neodontics Inc on January 24, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Neodontics Inc
- Inspection Date: 2023-01-24
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Neodontics Inc, a Class II medical device manufacturer of dental alloys in Sun Valley, CA, revealed two significant observations. The firm failed to maintain device history records for its dental alloys and did not establish unique device identifiers (UDI) for its products, which were also missing from the device history records.

## Related Documents

- [483 - 2020-01-17](https://www.keypedia.com/records/483/neodontics-inc/cfc265b0-935c-463a-a727-eb853e109f8d)

## Related Officers

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

Company: https://www.keypedia.com/companies/neodontics-inc/288e274e-7e78-4df0-a90d-a65e5e8306bd

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