FDA inspection
Acist Medical Systems: FDA inspection ending Mar 4, 2019
FDA inspection 1081356 · Voluntary Action Indicated (VAI) · Eden Prairie, MN
Key facts
| Inspection ID | 1081356 |
|---|---|
| Firm | Acist Medical Systems |
| FEI number | 3001726808 |
| Address | 7905 Fuller Rd |
| City | Eden Prairie |
| State | MN |
| ZIP | 55344 |
| Country | United States |
| Fiscal year | 2019 |
| Inspection end date | Mar 4, 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