FDA inspection
Westone Laboratories, Inc.: FDA inspection ending Jul 12, 2012
FDA inspection 790503 · Official Action Indicated (OAI) · Colorado Springs, CO
Key facts
| Inspection ID | 790503 |
|---|---|
| Firm | Westone Laboratories, Inc. |
| FEI number | 2094377 |
| Address | 2235 Executive Cir |
| City | Colorado Springs |
| State | CO |
| ZIP | 80906 |
| Country | United States |
| Fiscal year | 2012 |
| Inspection end date | Jul 12, 2012 |
| Classification | Official Action Indicated (OAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
| Warning letter | 339913 |
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