Warning letter
Stockert GmbH: warning letter of Apr 14, 2015
FDA warning letter 446574 · Center for Devices and Radiological Health
Key facts
| Reference number | 446574 |
|---|---|
| Company | Stockert GmbH |
| Subject | CGMP/QSR/Medical Devices/Adulterated/Misbranded |
| Issue date | Apr 14, 2015 |
| Posted date | May 26, 2015 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 806, 806.10, 820 |
| Inspection city | Freiburg Im Breisgau |
| Inspection start date | Nov 10, 2014 |
| 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: