Warning letter
ERBE Elektromedizin GmbH: warning letter of Feb 25, 2000
FDA warning letter UCM068160 · Center for Devices and Radiological Health
Key facts
| Reference number | UCM068160 |
|---|---|
| Company | ERBE Elektromedizin GmbH |
| Subject | Electrosurgical Systems/Lack Premarket Norification/Quality System Regulation |
| Issue date | Feb 25, 2000 |
| Posted date | Feb 25, 2000 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 820, 820.40 |
| Country | 3 |
| Inspection city | Tubingen |
| Inspection start date | Oct 18, 1999 |
| 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: