Warning letter
Gambro Dialysatoren, GmbH [ARCHIVED]: warning letter of Sep 4, 2009
FDA warning letter 74544 · Center for Devices and Radiological Health
Key facts
| Reference number | 74544 |
|---|---|
| Company | Gambro Dialysatoren, GmbH [ARCHIVED] |
| Subject | Medical Device Reporting Regulation/Misbranded |
| Issue date | Sep 4, 2009 |
| Posted date | Sep 4, 2009 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 803, 803.3, 803.50(a)(1), 803.50(a)(2) |
| Inspection city | Hechingen |
| Inspection start date | May 4, 2009 |
| 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: