FDA inspection
Spectranetics Corporation: FDA inspection ending Jan 21, 2016
FDA inspection 956408 · Official Action Indicated (OAI) · Colorado Springs, CO
Key facts
| Inspection ID | 956408 |
|---|---|
| Firm | Spectranetics Corporation |
| FEI number | 3007284006 |
| Address | 9965 Federal Dr |
| City | Colorado Springs |
| State | CO |
| ZIP | 80921 |
| Country | United States |
| Fiscal year | 2016 |
| Inspection end date | Jan 21, 2016 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 491979 |
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
- 10–99 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