Warning letter
Colon Therapeutics: warning letter of Oct 23, 2003
FDA warning letter UCM147792 · Dallas District Office
Key facts
| Reference number | UCM147792 |
|---|---|
| Company | Colon Therapeutics |
| Subject | Lacks Premarket Approval/Labeling/Misbranded |
| Issue date | Oct 23, 2003 |
| Posted date | Oct 23, 2003 |
| Issuing office | Dallas District Office |
| Product type | Devices |
| CFR sections cited | 801.109, 803.50, 801.109(b)(1), 803.50(a)(1), 803.50(b)(2), 876.5220, 876.5220(b)(2), 876.5210 |
| Country | 3 |
| Inspection city | Houston |
| Inspection ZIP | 77073 |
| Inspection start date | Dec 12, 2002 |
| 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: