SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD. – FDA Inspection, May 14, 2015

Record Details

This FDA Inspection record concerns SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD., with an inspection on May 14, 2015, issued by the Center for Devices and Radiological Health, covering devices.

Company: SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD.
Inspection Date: May 14, 2015
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 8690e03d-4d38-4a66-8373-c4d22d0e9495

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 934008
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.30(d)Design output - documentation
21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements

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FDA Inspection

SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD.May 14, 2015