GIE Medical, Inc. – FDA Inspection, Sep 28, 2026

Record Details

This FDA Inspection record concerns GIE Medical, Inc., with an inspection on September 28, 2026, issued by the Minneapolis District Office, covering medical devices & rad health.

Company: GIE Medical, Inc.
Inspection Date: September 28, 2026
Product Type: Medical Devices & Rad Health
Office: Minneapolis District Office
Person: Sharon L. Matson (FDA Associated Person)

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ID · 066d0d99-8432-48e1-93d2-96e25a451f43

Inspection Facts

Inspection number: 1338132
FDA center: Medical Devices & Rad Health
Project area: Project Evaluation: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 812.150(b)(5)Sponsor progress reports for significant risk study
21 CFR 812.5(a)Label does not contain required information

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FDA Inspection

GIE Medical, Inc.September 28, 2026