FDA inspection
K2M, Inc.: FDA inspection ending Nov 16, 2016
FDA inspection 992904 · Voluntary Action Indicated (VAI) · Leesburg, VA
Key facts
| Inspection ID | 992904 |
|---|---|
| Firm | K2M, Inc. |
| FEI number | 3008599177 |
| Address | 600 Hope Pkwy SE |
| City | Leesburg |
| State | VA |
| ZIP | 20175 |
| Country | United States |
| Fiscal year | 2017 |
| Inspection end date | Nov 16, 2016 |
| 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
- 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