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FDA inspection

Nihon Kohden Digital Health Solutions, LLC.: FDA inspection ending Feb 24, 2026

FDA inspection 1306654 · Irvine, CA

Key facts

Inspection ID 1306654
Firm Nihon Kohden Digital Health Solutions, LLC.
FEI number 3003142870
Address 14 Bunsen
City Irvine
State CA
ZIP 92618-4210
Fiscal year 2026
Inspection end date Feb 24, 2026
Project area Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices
Product type Devices
Warning letter 727803

At a glance

  • None Citations
  • None Posted citations
  • Yes Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 1–9 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

Other inspections at this establishment

About FDA inspections

FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

Source: U.S. Food and Drug Administration (FDA), inspection classification data

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