AvantSonic Technology Co., Ltd. – FDA Inspection, Aug 20, 2026

Record Details

This FDA Inspection record concerns AvantSonic Technology Co., Ltd., with an inspection on August 20, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: AvantSonic Technology Co., Ltd.
Inspection Date: August 20, 2026
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: Esteban Beltran (Issuing Officer)

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ID · da555c88-b685-4693-a34b-75bdd16eeeb7

Inspection Facts

Inspection number: 1335066
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices
Outcome: Form 483 issued

FDA Citations

ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
ISO 13485:2016 Clause 8.2.2Complaint handling records not maintained

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FDA Inspection

AvantSonic Technology Co., Ltd.August 20, 2026