CryoIQ Global AB – FDA Inspection, Sep 10, 2026

Record Details

This FDA Inspection record concerns CryoIQ Global AB, with an inspection on September 10, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: CryoIQ Global AB
Inspection Date: September 10, 2026
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: Brian R. Hendricks (Investigator)

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ID · b8b04422-d65e-4baf-823c-3bf3e967050c

Inspection Facts

Inspection number: 1335038
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

ISO 13485:2016 Clause 7.1Product realization risk management processes not documented

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FDA Inspection

CryoIQ Global ABSeptember 10, 2026