FDA inspection
O2 Concepts, LLC: FDA inspection ending Jan 10, 2018
FDA inspection 1037620 · Voluntary Action Indicated (VAI) · Middlebury, CT
Key facts
| Inspection ID | 1037620 |
|---|---|
| Firm | O2 Concepts, LLC |
| FEI number | 3008910673 |
| Address | 199 Park Road Ext Ste B |
| City | Middlebury |
| State | CT |
| ZIP | 06762 |
| Country | United States |
| Fiscal year | 2018 |
| Inspection end date | Jan 10, 2018 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: 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