# FDA 483 - DiamoDent, Inc. - November 04, 2021

Source: https://www.keypedia.com/records/483/diamodent-inc/a2901c2a-5633-4efd-9a76-b95712a093a6

> FDA 483 for DiamoDent, Inc. on November 04, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DiamoDent, Inc.
- Inspection Date: 2021-11-04
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: DiamoDent, Inc. in Anaheim, CA, a medical device manufacturer, was inspected by the FDA from November 1-4, 2021. The inspection revealed significant deficiencies in quality system procedures, including unvalidated production software, undocumented management reviews, and issues with internal quality audits where the auditor had direct responsibility for the matters being audited and audits were not consistently performed or documented. These findings indicate a lack of adherence to established quality system requirements.

## Related Officers

- [Creighton T. Tuzon](https://www.keypedia.com/people/creighton-t-tuzon/be0d09c0-59f4-48c3-9e3d-a1ceb2587e3e)

Company: https://www.keypedia.com/companies/diamodent-inc/ba2e518f-c5e0-4022-a2b5-b3d52e8fe2b0

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