Warning letter
Westone Laboratories Incorporated: warning letter of Oct 23, 2012
FDA warning letter 339913 · Denver District Office
Key facts
| Reference number | 339913 |
|---|---|
| Company | Westone Laboratories Incorporated |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Oct 23, 2012 |
| Posted date | Oct 23, 2012 |
| Issuing office | Denver District Office |
| Product type | Devices |
| CFR sections cited | 820, 820.40, 807.81(b) |
| Inspection city | Colorado Springs |
| Inspection ZIP | 80906 |
| Inspection start date | Jul 2, 2012 |
| 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: