Warning letter
Lux Therapeutics LLC dba Ponya Therapeutics LLC: warning letter of Nov 25, 2025
FDA warning letter 720001 · Office of Compliance and Biologics Quality
Key facts
| Reference number | 720001 |
|---|---|
| Company | Lux Therapeutics LLC dba Ponya Therapeutics LLC |
| Subject | Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA) |
| Issue date | Nov 25, 2025 |
| Posted date | Dec 9, 2025 |
| Issuing office | Office of Compliance and Biologics Quality |
| Product type | Biologics |
| CFR sections cited | 1271.230(a), 1271, 1271.55(a), 1271.55(a)(2), 1271.55(b)(2) |
| Inspection city | Brookhaven |
| Inspection ZIP | 30329-1906 |
| Inspection start date | Jun 2, 2025 |
| 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: