Inmedix, Inc. – FDA Inspection, Mar 20, 2026

Record Details

This FDA Inspection record concerns Inmedix, Inc., with an inspection on March 20, 2026, issued by the Seattle District Office, covering medical devices & rad health.

Company: Inmedix, Inc.
Inspection Date: March 20, 2026
Product Type: Medical Devices & Rad Health
Office: Seattle District Office
Person: Brian R. Hendricks (Investigator)

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ID · 25d10ca6-f54a-4db9-9d14-ba7c58663b6d

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number: 1308290
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Medical Devices
Outcome: Form 483 issued, view the record

FDA Citations

ISO 13485:2016 Clause 5.6.1Management review procedures not documented
ISO 13485:2016 Clause 7.3.7Design and development validation not performed as planned
ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented

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FDA Inspection

Inmedix, Inc.March 20, 2026