Warning letter
Somnowell, Inc.: warning letter of May 12, 2016
FDA warning letter 493804 · New Orleans District Office
Key facts
| Reference number | 493804 |
|---|---|
| Company | Somnowell, Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | May 12, 2016 |
| Posted date | May 24, 2016 |
| Issuing office | New Orleans District Office |
| Product type | Devices |
| CFR sections cited | 820, 820.40 |
| Inspection city | Bellevue |
| Inspection ZIP | 37221 |
| Inspection start date | Feb 11, 2016 |
| 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: