Warning letter
Oxysure Systems, Inc.: warning letter of Dec 8, 2014
FDA warning letter 446086 · Dallas District Office
Key facts
| Reference number | 446086 |
|---|---|
| Company | Oxysure Systems, Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Dec 8, 2014 |
| Posted date | Jan 20, 2015 |
| Issuing office | Dallas District Office |
| Product type | Devices |
| CFR sections cited | 820.3, 820, 806.20(b)(4), 806.2(i), 806, 820.3(b) |
| Inspection city | Frisco |
| Inspection ZIP | 75033 |
| Inspection start date | Sep 3, 2014 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: