FDA inspection
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): FDA inspection ending Aug 16, 2018
FDA inspection 1157919 · Voluntary Action Indicated (VAI) · Mounds View, MN
Key facts
| Inspection ID | 1157919 |
|---|---|
| Firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| FEI number | 2182208 |
| Address | 8200 Coral Sea St Ne |
| City | Mounds View |
| State | MN |
| ZIP | 55112-4391 |
| Fiscal year | 2018 |
| Inspection end date | Aug 16, 2018 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Medical 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
- 10–99 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