Kenzmedico Co., Ltd. – FDA Inspection, Jan 26, 2017

Record Details

This FDA Inspection record concerns Kenzmedico Co., Ltd., with an inspection on January 26, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: Kenzmedico Co., Ltd.
Inspection Date: January 26, 2017
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: Thai T. Duong (Issuing Officer)

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ID · 19c31528-e056-4078-a525-9bb19ece8ea0

Inspection Facts

Inspection number: 1000853
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 803.17Lack of Written MDR Procedures

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FDA Inspection

Kenzmedico Co., Ltd.January 26, 2017