FDA WARNING_LETTER - Wintech Medipro LLC - July 06, 2022

FDA WARNING_LETTER for Wintech Medipro LLC on July 06, 2022. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Wintech Medipro LLC on July 06, 2022. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.22

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

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

21 CFR 820.30(a)

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

21 CFR 820.100(a)

21 CFR 820

21 U.S.C. 321(h)

21 U.S.C. 360(k)

21 CFR 878.4040

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Record Information

Company

Wintech Medipro LLC

Inspection Date

July 6, 2022

Product Type

Devices

Office

Division of Medical Device and Radiological Health Operations East

People

ID: e3ffa1ee-91d3-4420-b2af-a547d349defb

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