# FDA 483 - Tristar Dental Laboratory, Inc - July 23, 2019

Source: https://www.keypedia.com/records/483/tristar-dental-laboratory-inc/2632dbe7-93d0-4e01-86b3-6e3fd0c8bf84

> FDA 483 for Tristar Dental Laboratory, Inc on July 23, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tristar Dental Laboratory, Inc
- Inspection Date: 2019-07-23
- Product Type: device
- Office Name: Dallas District Office
- Summary: An FDA inspection of Tristar Dental Laboratory, Inc. in Houston, TX, a specification developer for dental manufacturing, identified two significant observations. The firm failed to establish procedures for receiving, reviewing, and evaluating complaints, and also lacked written Medical Device Reporting (MDR) procedures. These deficiencies indicate a lack of adequate quality system controls for post-market surveillance.

## Related Officers

- [Jocelyn C. Turner](https://www.keypedia.com/people/jocelyn-c-turner/7e39f6e0-9750-4460-8a4e-27ee9306b77e)

Company: https://www.keypedia.com/companies/tristar-dental-laboratory-inc/477e7d78-df17-4136-99be-a0afbef38c43

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