FDA inspection
Kentec Medical, Inc: FDA inspection ending May 11, 2015
FDA inspection 928285 · Voluntary Action Indicated (VAI) · Irvine, CA
Key facts
| Inspection ID | 928285 |
|---|---|
| Firm | Kentec Medical, Inc |
| FEI number | 2080225 |
| Address | 17871 Fitch |
| City | Irvine |
| State | CA |
| ZIP | 92614 |
| Country | United States |
| Fiscal year | 2015 |
| Inspection end date | May 11, 2015 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
At a glance
- None 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