Warning letter
Visgeneer, Inc: warning letter of Jun 13, 2025
FDA warning letter 709010 · Center for Devices and Radiological Health
Key facts
| Reference number | 709010 |
|---|---|
| Company | Visgeneer, Inc |
| Subject | CGMP/QSR/Medical Devices/Adulterated/Misbranded |
| Issue date | Jun 13, 2025 |
| Posted date | Aug 5, 2025 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 806, 820, 820.3, 806.10, 862.9(a) |
| Inspection city | Hsinchu City |
| Inspection start date | Feb 24, 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: