FDA WARNING_LETTER - Unimicro Medical Systems-Shenzhen Co., Ltd. - September 26, 2021

FDA WARNING_LETTER for Unimicro Medical Systems-Shenzhen Co., Ltd. on September 26, 2021. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Unimicro Medical Systems-Shenzhen Co., Ltd. on September 26, 2021. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.75(b)

21 CFR 820.30(a)

21 CFR 820.80(c)

21 CFR 820.100(a)

21 CFR 820

21 CFR 820.72(a)

21 U.S.C. 321(h)

21 CFR 820.90(a)

21 U.S.C. 381(a)

21 U.S.C. 351(h)

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Record Information

Company

Unimicro Medical Systems-Shenzhen Co., Ltd.

Inspection Date

September 26, 2021

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Courtney H. Lias (Acting Director)

ID: f851eb00-8c89-4510-a5c0-8484e997c1b6

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