Warning letter
INCELL Corporation, LLC: warning letter of Dec 6, 2006
FDA warning letter UCM076201 · Center for Biologics Evaluation and Research
Key facts
| Reference number | UCM076201 |
|---|---|
| Company | INCELL Corporation, LLC |
| Subject | GLP/Bioresearch Monitoring Program/Investigational drugs |
| Issue date | Dec 6, 2006 |
| Posted date | Dec 6, 2006 |
| Issuing office | Center for Biologics Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 58, 58.35, 58.81, 58.105(d), 58.105, 58.120, 58.185, 58.63(a), 58.81(b)(6), 58.81(b)(11), 58.120(a)(7), 58.185(a)(11) and 1 more |
| Country | 3 |
| Inspection city | San Antonio |
| Inspection ZIP | 78249-3424 |
| Inspection start date | Sep 5, 2006 |
| Letter on fda.gov | web.archive.org |
At a glance
- 10–99 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: