FDA WARNING_LETTER - Zhejiang Xichen Medical Technology Co., Ltd. - March 23, 2021

FDA WARNING_LETTER for Zhejiang Xichen Medical Technology Co., Ltd. on March 23, 2021. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Zhejiang Xichen Medical Technology Co., Ltd. on March 23, 2021. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 360j(g)

21 U.S.C. 352(a)

21 U.S.C. 351(f)(1)(B)

21 U.S.C. 321(h)

21 U.S.C. 360(k)

21 U.S.C. 360e(a)

21 CFR 807.39

21 U.S.C. 352(o)

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Record Information

Company

Zhejiang Xichen Medical Technology Co., Ltd.

Inspection Date

March 23, 2021

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: e5bba548-55bc-4932-878f-442dba8275ac

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