FDA inspection
Gentherm Medical, LLC: FDA inspection ending Aug 30, 2018
FDA inspection 1063862 · Voluntary Action Indicated (VAI) · Blue Ash, OH
Key facts
| Inspection ID | 1063862 |
|---|---|
| Firm | Gentherm Medical, LLC |
| FEI number | 1516825 |
| Address | 12011 Mosteller Rd Fl 3 |
| City | Blue Ash |
| State | OH |
| ZIP | 45241 |
| Country | United States |
| Fiscal year | 2018 |
| Inspection end date | Aug 30, 2018 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Postmarket Assurance: 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
- 10–99 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