Warning letter
Sorin Group Deutschland GmbH: warning letter of Dec 29, 2015
FDA warning letter 484629 · Center for Devices and Radiological Health
Key facts
| Reference number | 484629 |
|---|---|
| Company | Sorin Group Deutschland GmbH |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Dec 29, 2015 |
| Posted date | Jan 5, 2016 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 803, 803.17, 806, 806.10, 820, 803.50(a), 807.81(b) |
| Inspection city | Munich |
| Inspection start date | Aug 24, 2015 |
| 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: