# FDA 483 - Tiadent Inc - February 11, 2026

Source: https://www.globalkeysolutions.net/records/483/tiadent-inc/921942ba-1525-478d-87ec-750c9968b275

> FDA 483 for Tiadent Inc on February 11, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tiadent Inc
- Inspection Date: 2026-02-11
- Product Type: device
- Office Name: Dallas District Office
- Summary: Tiadent Inc, a manufacturer and initial importer of medical devices in Rosenberg, TX, was cited for three significant issues during an FDA inspection. The firm failed to implement a risk-based approach for its Class II medical devices, lacked proper Medical Device Reporting (MDR) procedures, and did not comply with Unique Device Identification (UDI) requirements for its medical device labels and GUDID registration. These observations indicate deficiencies in the firm's quality management system and regulatory compliance.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/tiadent-inc/de70d3a5-4b5a-4192-ab80-9f6a12a0759b

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