Warning letter
Cochlear Bone Anchored Solutions AB: warning letter of Feb 20, 2008
FDA warning letter UCM1048394 · Center for Devices and Radiological Health
Key facts
| Reference number | UCM1048394 |
|---|---|
| Company | Cochlear Bone Anchored Solutions AB |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Feb 20, 2008 |
| Posted date | Feb 20, 2008 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 820.40, 803.50(a), 803, 803.3, 803.50(a)(2), 820 |
| Country | 3 |
| Inspection city | Molnlycke |
| Inspection start date | May 14, 2007 |
| 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: