Warning letter
Centrix Pharmaceutical Inc.: warning letter of Feb 26, 2007
FDA warning letter UCM076290 · Center for Drug Evaluation and Research
Key facts
| Reference number | UCM076290 |
|---|---|
| Company | Centrix Pharmaceutical Inc. |
| Subject | Marketing an unapproved new drug - ergotamine tartrate |
| Issue date | Feb 26, 2007 |
| Posted date | Feb 26, 2007 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 310.6(b)(1), 201.5, 201.115, 310.6(b)(2) |
| 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: