Warning letter
Nihon Kohden Digital Health Solutions, LLC: warning letter of Jun 12, 2026
FDA warning letter 727803 · Center for Devices and Radiological Health
Key facts
| Reference number | 727803 |
|---|---|
| Company | Nihon Kohden Digital Health Solutions, LLC |
| Subject | Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) |
| Issue date | Jun 12, 2026 |
| Posted date | Jul 14, 2026 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 807.81(b)(1)(i), 807.81(a)(3)(i), 807.81(a)(3)(ii), 870.1025 |
| Inspection city | Irvine |
| Inspection ZIP | 92618-4210 |
| Inspection start date | Feb 23, 2026 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- 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: