Warning letter
Terumo Cardiovascular Systems: warning letter of Aug 31, 2006
FDA warning letter UCM076049 · Detroit District Office
Key facts
| Reference number | UCM076049 |
|---|---|
| Company | Terumo Cardiovascular Systems |
| Subject | Quality System Regulations for Medical Device Reporting/Misbranded |
| Issue date | Aug 31, 2006 |
| Posted date | Aug 31, 2006 |
| Issuing office | Detroit District Office |
| Product type | Devices |
| CFR sections cited | 803, 806, 803.50(a)(2) |
| Country | 3 |
| Inspection city | Ann Arbor |
| Inspection ZIP | 48103-9586 |
| Inspection start date | Dec 6, 2005 |
| 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: