Warning letter
Dornier Medtech America, Inc.: warning letter of Jun 1, 2007
FDA warning letter UCM076407 · Atlanta District Office
Key facts
| Reference number | UCM076407 |
|---|---|
| Company | Dornier Medtech America, Inc. |
| Subject | Medical Device Reporting Regulation/Misbranded |
| Issue date | Jun 1, 2007 |
| Posted date | Jun 1, 2007 |
| Issuing office | Atlanta District Office |
| Product type | Devices |
| CFR sections cited | 803.50(a)(2), 803, 803.17 |
| Country | 3 |
| Inspection city | Kennesaw |
| Inspection ZIP | 30144-3600 |
| Inspection start date | Feb 20, 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: