Warning letter
R82 A/S [ARCHIVED]: warning letter of Mar 14, 2011
FDA warning letter 160712 · Center for Devices and Radiological Health
Key facts
| Reference number | 160712 |
|---|---|
| Company | R82 A/S [ARCHIVED] |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Mar 14, 2011 |
| Posted date | Mar 14, 2011 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 803, 803.17, 820, 803.50(a) |
| Inspection city | Gedved |
| Inspection start date | Oct 4, 2010 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- VAI 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: