Warning letter
Tonica Elektronik A/S: warning letter of Nov 6, 2012
FDA warning letter 361479 · Center for Devices and Radiological Health
Key facts
| Reference number | 361479 |
|---|---|
| Company | Tonica Elektronik A/S |
| Subject | Quality System Regulation for Medical Devices/Adulterated/Misbranded |
| Issue date | Nov 6, 2012 |
| Posted date | Nov 6, 2012 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 820, 807.81(a)(3)(ii), 807.81(b) |
| Inspection city | Farum |
| Inspection start date | Jul 30, 2012 |
| 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: