Warning letter
Gyrus Medical [ARCHIVED]: warning letter of Jan 10, 2011
FDA warning letter 144072 · Center for Devices and Radiological Health
Key facts
| Reference number | 144072 |
|---|---|
| Company | Gyrus Medical [ARCHIVED] |
| Subject | Medical Device Reporting/Misbranded |
| Issue date | Jan 10, 2011 |
| Posted date | Jan 10, 2011 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 803, 803.3, 803.17, 803.56, 820 |
| Inspection city | Cardiff |
| Inspection start date | Aug 2, 2010 |
| 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: