Hu-Friedy Medical Instrument (Shanghai) Co. Ltd. – FDA Inspection, Apr 18, 2014

Record Details

This FDA Inspection record concerns Hu-Friedy Medical Instrument (Shanghai) Co. Ltd., with an inspection on April 18, 2014, issued by the Center for Devices and Radiological Health, covering devices.

Company: Hu-Friedy Medical Instrument (Shanghai) Co. Ltd.
Inspection Date: April 18, 2014
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · adce5b53-3d43-4ca6-a5b6-9dcbf9ff1d5a

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 876148
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.198(c)Investigation of device failures
21 CFR 820.70(a)Production processes

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FDA Inspection

Hu-Friedy Medical Instrument (Shanghai) Co. Ltd.April 18, 2014