Warning letter
Sleep Devices, Inc.: warning letter of Mar 28, 2007
FDA warning letter UCM076338 · Florida District Office
Key facts
| Reference number | UCM076338 |
|---|---|
| Company | Sleep Devices, Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Mar 28, 2007 |
| Posted date | Mar 28, 2007 |
| Issuing office | Florida District Office |
| Product type | Devices |
| CFR sections cited | 803.17, 100, 820 |
| Country | 3 |
| Inspection city | Kissimmee |
| Inspection ZIP | 34741-4114 |
| Inspection start date | Jan 16, 2007 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- VAI 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: