Warning letter
Eli Lilly and Company: warning letter of Sep 9, 2025
FDA warning letter 716462 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 716462 |
|---|---|
| Company | Eli Lilly and Company |
| Subject | False & Misleading Claims/Misbranded |
| Issue date | Sep 9, 2025 |
| Posted date | Sep 16, 2025 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| CFR sections cited | 202.1, 314.81(b)(3)(i) |
| Country | 3 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
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: