FDA inspection
Electromedical Products International, Inc.: FDA inspection ending Feb 1, 2013
FDA inspection 816802 · Official Action Indicated (OAI) · Mineral Wells, TX
Key facts
| Inspection ID | 816802 |
|---|---|
| Firm | Electromedical Products International, Inc. |
| FEI number | 2020648 |
| Address | 2201 Garrett Morris Pkwy |
| City | Mineral Wells |
| State | TX |
| ZIP | 76067 |
| Country | United States |
| Fiscal year | 2013 |
| Inspection end date | Feb 1, 2013 |
| Classification | Official Action Indicated (OAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
| Warning letter | 396441 |
At a glance
- 1–9 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