FDA inspection
Thermotek, Inc.: FDA inspection ending Jul 22, 2016
FDA inspection 981384 · Voluntary Action Indicated (VAI) · Flower Mound, TX
Key facts
| Inspection ID | 981384 |
|---|---|
| Firm | Thermotek, Inc. |
| FEI number | 3000204260 |
| Address | 1200 Lakeside Pkwy Ste 200 |
| City | Flower Mound |
| State | TX |
| ZIP | 75028 |
| Country | United States |
| Fiscal year | 2016 |
| Inspection end date | Jul 22, 2016 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data