Winiadaewoo Microwave Oven (Tianjin) Co., Ltd., Dagang, China – FDA Inspections

Inspection records and compliance data for Winiadaewoo Microwave Oven (Tianjin) Co., Ltd. in Dagang. 7 FDA inspections on record (1 OAI), 2 Form 483s, last inspected June 06, 2019.

Company Profile

This profile covers Winiadaewoo Microwave Oven (Tianjin) Co., Ltd. based in Dagang, China.

FDA Inspection History

FDA inspections: 7
OAI: 1
VAI: 5
NAI: 1
Form 483s: 2
Warning letters: 0

First inspected March 19, 2009. Last inspected June 6, 2019.

Most cited issue areas

Certification not based on adequate test/testing program2 inspections
Means to monitor interlocks1 inspection
tests--errors and uncertainties accounted for1 inspection

FDA inspections (7)

Date	Result	FDA center(s)	Insp. #
June 6, 2019	VAI	Medical Devices & Rad Health · Radiation Control and Health Safety Act	1096063
May 9, 2017	VAI	Medical Devices & Rad Health · Radiation Control and Health Safety Act	1024290
June 23, 2015	VAI	Medical Devices & Rad Health · Radiation Control and Health Safety Act	935023
April 23, 2014	NAI	Medical Devices & Rad Health · Radiation Control and Health Safety Act	887020
June 8, 2011	OAI	Medical Devices & Rad Health · Radiation Control and Health Safety Act	734265
May 14, 2010	VAI	Medical Devices & Rad Health · Radiation Control and Health Safety Act	666782
March 19, 2009	VAI	Medical Devices & Rad Health · Radiation Control and Health Safety Act	576508

FDA documents

No Form 483s, Warning Letters or EIRs on record.

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