Warning letter
Avertix Medical, Inc.: warning letter of Sep 3, 2025
FDA warning letter 711080 · Center for Devices and Radiological Health
Key facts
| Reference number | 711080 |
|---|---|
| Company | Avertix Medical, Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Sep 3, 2025 |
| Posted date | Mar 17, 2026 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 820, 803, 803.3(k), 803.3(o)(2)(i), 803.3(o)(2)(ii), 803.3(w), 803.12(a), 803.17, 803.17(a)(3), 803.19, 803.50(a)(1), 803.50(a)(2) and 5 more |
| Inspection city | Eatontown |
| Inspection ZIP | 07724 |
| Inspection start date | Feb 19, 2025 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 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: