FDA inspection
St. Jude Medical, Atrial Fibrillation Division, Inc.: FDA inspection ending Mar 29, 2019
FDA inspection 1084607 · Voluntary Action Indicated (VAI) · Saint Paul, MN
Key facts
| Inspection ID | 1084607 |
|---|---|
| Firm | St. Jude Medical, Atrial Fibrillation Division, Inc. |
| FEI number | 1000139754 |
| Address | One St. Jude Medical Drive |
| City | Saint Paul |
| State | MN |
| ZIP | 55117 |
| Country | United States |
| Fiscal year | 2019 |
| Inspection end date | Mar 29, 2019 |
| 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