Warning Letter — Nihon Kohden Digital Health Solutions, LLC
The FDA issued a Warning Letter to Nihon Kohden Digital Health Solutions, LLC on June 12, 2026, following an inspection by the Center for Devices and Radiological Health.
This action affects Nihon Kohden Digital Health Solutions, LLC and personnel responsible for regulatory compliance and quality systems within their digital health divisions.
A Warning Letter from CDRH typically indicates significant deviations from Quality System Regulations (QSR) or pre-market requirements. While the specific violations are not detailed in the provided excerpt, this action signals that the FDA has identified compliance deficiencies that require formal corrective actions to avoid further enforcement such as seizure or injunction. Regulatory teams should anticipate increased oversight of digital health solutions.
Quality and Regulatory teams should review current Digital Health compliance frameworks to ensure all software solutions meet Center for Devices and Radiological Health requirements. Conduct an internal audit of documentation cited in the warning letter once the full text is reviewed to identify potential gaps in internal Quality Management Systems (QMS).
FDA Warning Letter issued to: Nihon Kohden Digital Health Solutions, LLC. 06/12/2026 — Center for Devices and Radiological Health. Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nihon-kohden-digital-health-solutions-llc-727803-06122026
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