FDA inspection
SMK Imaging LLC: FDA inspection ending Oct 23, 2019
FDA inspection 1108788 · Voluntary Action Indicated (VAI) · Elmsford, NY
Key facts
| Inspection ID | 1108788 |
|---|---|
| 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 | 2020 |
| Inspection end date | Oct 23, 2019 |
| 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