Wellysis CORP – FDA Inspection, Sep 10, 2026

Record Details

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

Company: Wellysis CORP
Inspection Date: September 10, 2026
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: Maryam Tabatabaie (Company Rep)

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ID · f51e4d0c-5d55-41bc-897c-363854ba1452

Inspection Facts

Inspection number: 1337478
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

ISO 13485:2016 Clause 4.1.6QMS software not validated prior to use or changes
ISO 13485:2016 Clause 7.3.7Design and development validation not complete prior to release of product
ISO 13485:2016 Clause 7.4.1Procedures for purchasing process not documented

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FDA Inspection

Wellysis CORPSeptember 10, 2026