# FDA 483 - Neodontics Inc - January 17, 2020

Source: https://www.keypedia.com/records/483/neodontics-inc/cfc265b0-935c-463a-a727-eb853e109f8d

> FDA 483 for Neodontics Inc on January 17, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Neodontics Inc
- Inspection Date: 2020-01-17
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Neodontics Inc, a medical device manufacturer in Sun Valley, CA, was inspected by the FDA from January 16-17, 2020. The inspection revealed a significant issue regarding the maintenance of device history records for its Dental Alloys products. This indicates a fundamental lapse in quality system documentation.

## Related Documents

- [483 - 2023-01-24](https://www.keypedia.com/records/483/neodontics-inc/26cfd4a7-6279-4fc7-8d52-a9c304e6352b)

## Related Officers

- [investigator](https://www.keypedia.com/people/sarah-a-hassas/4f142d54-fc28-4bd5-82ad-7e6fa443688c)

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