Warning letter
3B Medical, Inc. dba Reach Health, Inc.: warning letter of May 20, 2026
FDA warning letter 725108 · Center for Devices and Radiological Health
Key facts
| Reference number | 725108 |
|---|---|
| Company | 3B Medical, Inc. dba Reach Health, Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | May 20, 2026 |
| Posted date | Jun 30, 2026 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 806, 806.10, 807.81(a)(3), 807.81(a)(3)(i), 807.81(b), 820 |
| Inspection city | Dublin |
| Inspection ZIP | 43017 |
| Inspection start date | Dec 1, 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: