# FDA 483 - Dentlight Inc - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/dentlight-inc/b3ab6acb-ff47-4dee-9bec-705b92ed6285

> FDA 483 for Dentlight Inc on Unknown Date. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dentlight Inc
- Product Type: device
- Office Name: Dallas District Office
- Summary: An FDA inspection of Dentlight, Inc., a device manufacturer in Plano, TX, revealed two significant observations. The firm's internal quality audits were conducted by an individual directly responsible for the audited matters, and change records for controlled documents lacked descriptions of the changes and their effective dates.

## Related Documents

- [483 - 2023-08-23](https://www.globalkeysolutions.net/records/483/dentlight-inc/bad0da5e-647e-4d6b-b74c-f346517a6d72)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/gilbert-valdez/9226d7ad-71e9-41b0-977e-8de133999b6a)

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

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9