# FDA 483 - Dentlight Inc - August 23, 2023

Source: https://www.globalkeysolutions.net/records/483/dentlight-inc/bad0da5e-647e-4d6b-b74c-f346517a6d72

> FDA 483 for Dentlight Inc on August 23, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dentlight Inc
- Inspection Date: 2023-08-23
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Dentlight Inc in Plano, TX, revealed a significant quality system deficiency. The firm's internal quality audits were conducted by individuals who had direct responsibility for the matters being audited, compromising the independence of the audit process. This indicates a lack of proper controls for ensuring objective quality assessments.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/dentlight-inc/b3ab6acb-ff47-4dee-9bec-705b92ed6285)

## Related Officers

- [Christopher W. Buser](https://www.globalkeysolutions.net/people/christopher-w-buser/6a11d2e7-dcfa-4542-ba81-b4c6b244ef04)

Company: https://www.globalkeysolutions.net/companies/dentlight-inc/545221f5-e0ed-408a-b31f-5927f5e686de

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab