Warning letter
Qiagen GmbH: warning letter of Oct 2, 2006
FDA warning letter UCM076085 · Center for Devices and Radiological Health
Key facts
| Reference number | UCM076085 |
|---|---|
| Company | Qiagen GmbH |
| Subject | Lacks Premarket Approval Application Misbranded |
| Issue date | Oct 2, 2006 |
| Posted date | Oct 2, 2006 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 864.4020, 820.3, 807.81(b), 864.4020(a) |
| Country | 3 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
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: