ICU Medical Czech Republic a. s. – FDA Inspection, Sep 18, 2025

Record Details

This FDA Inspection record concerns ICU Medical Czech Republic a. s., with an inspection on September 18, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: ICU Medical Czech Republic a. s.
Inspection Date: September 18, 2025
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: Melanie W. Pishnery

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ID · 2eab4ea2-3d15-43ca-84ab-1128ba2e4cf2

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1282590
FDA center: Medical Devices & Rad Health
Project area: Compliance: Medical Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures

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FDA Inspection

ICU Medical Czech Republic a. s.September 18, 2025