FDA inspection
Nihon Kohden America LLC: FDA inspection ending Apr 30, 2019
FDA inspection 1088972 · Official Action Indicated (OAI) · Irvine, CA
Key facts
| Inspection ID | 1088972 |
|---|---|
| Firm | Nihon Kohden America LLC |
| FEI number | 2080783 |
| Address | 90 Icon |
| City | Irvine |
| State | CA |
| ZIP | 92618 |
| Country | United States |
| Fiscal year | 2019 |
| Inspection end date | Apr 30, 2019 |
| Classification | Official Action Indicated (OAI) |
| 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