FDA inspection
Ortho Kinematics, Inc: FDA inspection ending Dec 7, 2017
FDA inspection 1036361 · Referred to State (RTS) · West Lake Hills, TX
Key facts
| Inspection ID | 1036361 |
|---|---|
| Firm | Ortho Kinematics, Inc |
| FEI number | 3006172536 |
| Address | 110 Wild Basin Rd Ste 250 |
| City | West Lake Hills |
| State | TX |
| ZIP | 78746-3352 |
| Fiscal year | 2018 |
| Inspection end date | Dec 7, 2017 |
| Classification | Referred to State (RTS) |
| Project area | Compliance: Medical Devices |
| Product type | Devices |
At a glance
- None Citations
- None 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