FDA inspection
R2 Diagnostics, Inc.: FDA inspection ending Jan 31, 2018
FDA inspection 1040085 · Voluntary Action Indicated (VAI) · South Bend, IN
Key facts
| Inspection ID | 1040085 |
|---|---|
| Firm | R2 Diagnostics, Inc. |
| FEI number | 3000210416 |
| Address | 1801 Commerce Dr |
| City | South Bend |
| State | IN |
| ZIP | 46628 |
| Country | United States |
| Fiscal year | 2018 |
| Inspection end date | Jan 31, 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
- 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