FDA inspection
Tisenx, Inc.: FDA inspection ending May 12, 2021
FDA inspection 1144078 · No Action Indicated (NAI) · Irvine, CA
Key facts
| Inspection ID | 1144078 |
|---|---|
| Firm | Tisenx, Inc. |
| FEI number | 3016003911 |
| Address | 15615 Alton Pkwy Ste 450 |
| City | Irvine |
| State | CA |
| ZIP | 92618-3308 |
| Fiscal year | 2021 |
| Inspection end date | May 12, 2021 |
| Classification | No Action Indicated (NAI) |
| 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