Warning letter
Unomedical Device S.A. de C.V.: warning letter of Jan 8, 2026
FDA warning letter 719428 · Center for Devices and Radiological Health
Key facts
| Reference number | 719428 |
|---|---|
| Company | Unomedical Device S.A. de C.V. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Jan 8, 2026 |
| Posted date | Feb 3, 2026 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 820, 803.3, 803.50(a)(1), 803.50(a)(2) |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
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: