Tiadent Inc
Form 483 issued February 11, 2026 · Rosenberg, Texas
- Inspection
- Feb 10 – Feb 11, 2026
- Investigator
- Jocelyn C. Turner
- Observations
- 3
- Pages
- 5
- FEI number
- 3036042026
In short: On February 11, 2026, FDA issued a Form 483 with 3 observations to Tiadent Inc in Rosenberg, Texas (FEI 3036042026) after an inspection that ran Feb 10 – Feb 11, 2026. The investigator was Jocelyn C. Turner. Most observations concern cAPA.
At a glance
Observations span 1 system, led by capa.
What FDA observed
Preview: the opening words of each observation- 01ISO 13485:2016 Clause 4.1.2
A risk-based approach to the control of the appropriate processes needed for the quality management system…
- 0221 CFR 803.1721 CFR 803
Written MDR procedures have not been…
- 0321 CFR 801.20(a)21 CFR 830
The labels of the medical device(s) do not bear a unique device identifier (UDI) that meet…
This inspection in context
Jocelyn C. Turner
10 documents · 2015–2026
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Texas.
The firmTiadent Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.17
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Tiadent Inc?
FDA listed 3 observations on this Form 483, mostly about cAPA. The opening words of each observation are shown on this page.
Who inspected Tiadent Inc?
Jocelyn C. Turner is named on this Form 483, for the inspection of Feb 10 – Feb 11, 2026. Each investigator has a profile showing what they cite most.
When was Tiadent Inc inspected by FDA?
The inspection ran Feb 10 – Feb 11, 2026, and the Form 483 is dated February 11, 2026.
How do I get the full Form 483 for Tiadent Inc?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.