Winiadaewoo Microwave Oven (Tianjin) Co., Ltd. – FDA Inspection, May 9, 2017

Record Details

This FDA Inspection record concerns Winiadaewoo Microwave Oven (Tianjin) Co., Ltd., with an inspection on May 9, 2017, issued by the Center for Devices and Radiological Health, covering devices.

Company: Winiadaewoo Microwave Oven (Tianjin) Co., Ltd.
Inspection Date: May 9, 2017
Product Type: Devices
Office: Center for Devices and Radiological Health
People: Gregory M. Bessette (Issuing Officer)
Michael P. Sweeney (Issuing Officer)

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ID · aa0b6350-1dc2-41fe-b966-77ff2ec8b403

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1024290
FDA center: Medical Devices & Rad Health
Project area: Radiation Control and Health Safety Act
Outcome: Form 483 issued

FDA Citations

21 CFR 1030.10(c)(2)(vi)Means to monitor interlocks
21 CFR 1010.2(c)Certification not based on adequate test/testing program

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Winiadaewoo Microwave Oven (Tianjin) Co., Ltd.

Date	Classification	Office	Project area
June 6, 2019	VAI	Center for Devices and Radiological Health	Radiation Control and Health Safety Act
June 23, 2015	VAI	Center for Devices and Radiological Health	Radiation Control and Health Safety Act
April 23, 2014	NAI	Center for Devices and Radiological Health	Radiation Control and Health Safety Act
June 8, 2011	OAI	Center for Devices and Radiological Health	Radiation Control and Health Safety Act
May 14, 2010	VAI	Center for Devices and Radiological Health	Radiation Control and Health Safety Act