FDA inspection
Oto Med Inc: FDA inspection ending Aug 30, 2024
FDA inspection 1248206 · Voluntary Action Indicated (VAI) · Lake Havasu City, AZ
Key facts
| Inspection ID | 1248206 |
|---|---|
| Firm | Oto Med Inc |
| FEI number | 2021687 |
| Address | 1090 Empire Dr |
| City | Lake Havasu City |
| State | AZ |
| ZIP | 86404 |
| Country | United States |
| Fiscal year | 2024 |
| Inspection end date | Aug 30, 2024 |
| 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