Warning letter
LEVO AG: warning letter of Jul 18, 2025
FDA warning letter 717287 · Center for Devices and Radiological Health
Key facts
| Reference number | 717287 |
|---|---|
| Company | LEVO AG |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Jul 18, 2025 |
| Posted date | Oct 21, 2025 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 803.17, 806, 830, 890.3900, 830.300, 820, 820.5, 820.40, 803 |
| Inspection city | Wohlen Ag |
| Inspection start date | Apr 7, 2025 |
| 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: