Warning letter
Biora AB: warning letter of Dec 18, 2006
FDA warning letter UCM076214 · Center for Devices and Radiological Health
Key facts
| Reference number | UCM076214 |
|---|---|
| Company | Biora AB |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Dec 18, 2006 |
| Posted date | Dec 18, 2006 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 820, 803.50(a)(1), 803 |
| Country | 3 |
| Inspection city | Malmo |
| Inspection start date | Oct 23, 2006 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- 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: