FDA inspection
Epien Medical, Inc: FDA inspection ending Dec 11, 2013
FDA inspection 859099 · Voluntary Action Indicated (VAI) · White Bear Lake, MN
Key facts
| Inspection ID | 859099 |
|---|---|
| Firm | Epien Medical, Inc |
| FEI number | 3003428492 |
| Address | 4225 White Bear Pkwy Ste 600 |
| City | White Bear Lake |
| State | MN |
| ZIP | 55110 |
| Country | United States |
| Fiscal year | 2014 |
| Inspection end date | Dec 11, 2013 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
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
- 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