FDA Warning Letter — Nihon Kohden Digital Health Solutions, LLC.
The FDA took a Warning Letter action against Nihon Kohden Digital Health Solutions, LLC. on June 15, 2026 (Irvine, CA). The action was issued by CDRH and concerns devices products. This facility has 3 recent FDA inspections on record.
Action Details
- Facility
- Nihon Kohden Digital Health Solutions, LLC.
- Date
- June 15, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Center
- CDRH
- Location
- Irvine, CA (United States)