Warning letter
Westone Laboratories, Inc.: warning letter of May 22, 2006
FDA warning letter UCM075911 · Seattle District Office
Key facts
| Reference number | UCM075911 |
|---|---|
| Company | Westone Laboratories, Inc. |
| Subject | Current Good Manufacturing Practice Requirements for Medical Device Reporting (MDR) |
| Issue date | May 22, 2006 |
| Posted date | May 22, 2006 |
| Issuing office | Seattle District Office |
| Product type | Devices |
| CFR sections cited | 803.17 |
| Country | 3 |
| Inspection city | Colorado Springs |
| Inspection ZIP | 80906-4137 |
| Inspection start date | Mar 24, 2006 |
| 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: