Warning letter
System O2, Inc.: warning letter of Apr 30, 2003
FDA warning letter UCM147455 · Atlanta District Office
Key facts
| Reference number | UCM147455 |
|---|---|
| Company | System O2, Inc. |
| Subject | Quality System Regulation/Lacks Premarket Notification/Adulterated |
| Issue date | Apr 30, 2003 |
| Posted date | Apr 30, 2003 |
| Issuing office | Atlanta District Office |
| Product type | Devices |
| CFR sections cited | 807.81(b), 820, 807.81, 807.81(a)(3)(ii) |
| Country | 3 |
| Inspection city | Atlanta |
| Inspection ZIP | 30328 |
| Inspection start date | Dec 10, 2002 |
| 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: