Invisian Medical, LLC. – FDA Inspection, Mar 31, 2025

Record Details

This FDA Inspection record concerns Invisian Medical, LLC., with an inspection on March 31, 2025, issued by the Kansas City District Office, covering medical devices & rad health.

Company: Invisian Medical, LLC.
Inspection Date: March 31, 2025
Product Type: Medical Devices & Rad Health
Office: Kansas City District Office
Person: Eric C. Fox (Investigator)

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ID · cc37ac75-8ac5-4f6f-8445-4e8dbe5b18ec

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number: 1265811
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Medical Devices
Outcome: Form 483 issued, view the record

FDA Citations

21 CFR 820.30(g)Design validation - user needs and intended uses

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FDA Inspection

Invisian Medical, LLC.March 31, 2025