Warning letter
Replidyne, Inc.: warning letter of Jan 18, 2008
FDA warning letter UCM245508 · Center for Drug Evaluation and Research
Key facts
| Reference number | UCM245508 |
|---|---|
| Company | Replidyne, Inc. |
| Subject | Sponsor-Applicant-Monitor-Clinical Research Organization |
| Issue date | Jan 18, 2008 |
| Posted date | Jan 18, 2008 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 312.62(c), 314.50(d)(5)(iv), 314.3(b) |
| Country | 3 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
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: