WEARLINQ INC. – FDA Inspection, Nov 26, 2025

Record Details

This FDA Inspection record concerns WEARLINQ INC., with an inspection on November 26, 2025, issued by the Baltimore District Office, covering medical devices & rad health.

Company: WEARLINQ INC.
Inspection Date: November 26, 2025
Product Type: Medical Devices & Rad Health
Office: Baltimore District Office
People: Andrea D. Gomez (Issuing Officer)
Jude C. Dike (Investigator)

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ID · c17e66f0-2906-4191-9131-20f0808ee885

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number: 1292940
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Medical Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 801.20(a)Label to bear a unique device identifier
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.70(i)Software validation for automated processes

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FDA Inspection

WEARLINQ INC.November 26, 2025