FDA inspection
InControl Medical, LLC: FDA inspection ending Aug 21, 2012
FDA inspection 795977 · Official Action Indicated (OAI) · Pewaukee, WI
Key facts
| Inspection ID | 795977 |
|---|---|
| Firm | InControl Medical, LLC |
| FEI number | 3009466220 |
| Address | 3225 Gateway Rd Ste 250 |
| City | Pewaukee |
| State | WI |
| ZIP | 53072 |
| Country | United States |
| Fiscal year | 2012 |
| Inspection end date | Aug 21, 2012 |
| Classification | Official Action Indicated (OAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
| Warning letter | UCM328688 |
At a glance
- 10–99 Citations
- 1–9 Posted citations
- Yes Warning letter followed
- Yes Form FDA 483 issued
- Yes 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