Warning letter
INCELL Corporation LLC: warning letter of Dec 12, 2024
FDA warning letter 679023 · Center for Biologics Evaluation and Research (CBER)
Key facts
| Reference number | 679023 |
|---|---|
| Company | INCELL Corporation LLC |
| Subject | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| Issue date | Dec 12, 2024 |
| Posted date | Jan 21, 2025 |
| Issuing office | Center for Biologics Evaluation and Research (CBER) |
| Product type | Biologics |
| CFR sections cited | 1271, 211.113(b), 211.166(a), 1271.3(d) |
| Inspection city | San Antonio |
| Inspection ZIP | 78249 |
| Inspection start date | Sep 25, 2023 |
| Letter on fda.gov | fda.gov |
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: