FDA inspection
Biomedix Wai: FDA inspection ending Oct 31, 2019
FDA inspection 1110467 · Official Action Indicated (OAI) · Chanhassen, MN
Key facts
| Inspection ID | 1110467 |
|---|---|
| Firm | Biomedix Wai |
| FEI number | 1000115518 |
| Address | 3895 W Vernal Pike |
| City | Chanhassen |
| State | MN |
| ZIP | 55317 |
| Country | United States |
| Fiscal year | 2020 |
| Inspection end date | Oct 31, 2019 |
| Classification | Official Action Indicated (OAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
| Warning letter | 598171 |
At a glance
- 10–99 Citations
- 1–9 Posted citations
- Yes 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