FDA WARNING_LETTER - Wickimed Medical Equipment Manufacturing Co., Ltd. - September 14, 2021

FDA WARNING_LETTER for Wickimed Medical Equipment Manufacturing Co., Ltd. on September 14, 2021. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Wickimed Medical Equipment Manufacturing Co., Ltd. on September 14, 2021. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 352(t)(2)

21 CFR 820.30(a)

21 CFR 820.86

21 CFR 820

21 U.S.C. 321(h)

21 U.S.C. 381(a)

21 CFR 820.198(a)

21 CFR 820.75(a)

21 U.S.C. 351(h)

21 CFR 820.184

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Record Information

Company

Wickimed Medical Equipment Manufacturing Co., Ltd.

Inspection Date

September 14, 2021

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: 90794a9d-bc07-458b-8d14-a2776021e685

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