FDA inspection
Oxysure Systems, Inc.: FDA inspection ending Oct 3, 2014
FDA inspection 899019 · Official Action Indicated (OAI) · Frisco, TX
Key facts
| Inspection ID | 899019 |
|---|---|
| Firm | Oxysure Systems, Inc. |
| FEI number | 3004167951 |
| Address | 10880 John W Elliott Dr Ste 600 |
| City | Frisco |
| State | TX |
| ZIP | 75033 |
| Country | United States |
| Fiscal year | 2015 |
| Inspection end date | Oct 3, 2014 |
| Classification | Official Action Indicated (OAI) |
| Project area | Radiation Control and Health Safety Act |
| Product type | Devices |
| Warning letter | 446086 |
At a glance
- None Citations
- 1–9 Posted citations
- Yes 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