Warning letter
CARsgen Therapeutics Corporation: warning letter of Jul 26, 2024
FDA warning letter 686504 · Center for Biologics Evaluation and Research
Key facts
| Reference number | 686504 |
|---|---|
| Company | CARsgen Therapeutics Corporation |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Jul 26, 2024 |
| Posted date | Aug 27, 2024 |
| Issuing office | Center for Biologics Evaluation and Research |
| Product type | Biologics |
| CFR sections cited | 211.192, 211.42(c)(10)(iv), 211.42(c)(10)(v), 211.56(a), 211.100(a), 211.113(b), 312.21(b) |
| Inspection city | Durham |
| Inspection ZIP | 27703-9411 |
| Inspection start date | Nov 28, 2023 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- 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: