Warning letter
Diasol, Inc.: warning letter of Jan 29, 2026
FDA warning letter 719460 · Center for Devices and Radiological Health
Key facts
| Reference number | 719460 |
|---|---|
| Company | Diasol, Inc. |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) |
| Issue date | Jan 29, 2026 |
| Posted date | Mar 3, 2026 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 801, 801.3, 801.20(a), 801.40(a)(1), 801.40(a)(2), 803, 803.3, 803.3(k), 803.12(a), 803.17, 803.17(a)(1), 803.17(a)(3) and 11 more |
| Inspection city | Phoenix |
| Inspection ZIP | 85009 |
| Inspection start date | Jul 21, 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: