Warning letter
MED-EL ELEKTRO-MEDIZINISCHE GERATE GmbH: warning letter of Nov 16, 2004
FDA warning letter UCM146926 · Center for Devices and Radiological Health
Key facts
| Reference number | UCM146926 |
|---|---|
| Company | MED-EL ELEKTRO-MEDIZINISCHE GERATE GmbH |
| Subject | CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated |
| Issue date | Nov 16, 2004 |
| Posted date | Nov 16, 2004 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 803, 803.50, 820, 820.40 |
| Country | 3 |
| Inspection city | Innsbruck |
| Inspection start date | Jun 7, 2004 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- VAI 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: