FDA WARNING_LETTER - Dongguan Microview Medical Technology Co., LTD - June 27, 2019

FDA WARNING_LETTER for Dongguan Microview Medical Technology Co., LTD on June 27, 2019. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Dongguan Microview Medical Technology Co., LTD on June 27, 2019. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 321(h)

21 U.S.C. 351(h)

21 U.S.C. 381(a)

21 CFR 820

21 CFR 820.90(a)

21 CFR 820.75(a)

21 CFR 820.75(c)

21 CFR 820.100(a)(4)

21 CFR 820.86

21 CFR 820.25(b)

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Record Information

Company

Dongguan Microview Medical Technology Co., LTD

Inspection Date

June 27, 2019

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: 103815ff-6117-4837-b8cd-bd26a9dfe115

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