FDA inspection
SMK Imaging LLC: FDA inspection ending Apr 29, 2013
FDA inspection 830365 · Voluntary Action Indicated (VAI) · Elmsford, NY
Key facts
| Inspection ID | 830365 |
|---|---|
| Firm | SMK Imaging LLC |
| FEI number | 3010609444 |
| Address | 8 Westchester Plz Ste 112 Ste 240 |
| City | Elmsford |
| State | NY |
| ZIP | 10523 |
| Country | United States |
| Fiscal year | 2013 |
| Inspection end date | Apr 29, 2013 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
At a glance
- None 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