FDA WARNING_LETTER - Won Industry Co. LTD - April 11, 2019

FDA WARNING_LETTER for Won Industry Co. LTD on April 11, 2019. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Won Industry Co. LTD on April 11, 2019. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 820.100(a)

21 CFR 803.50(a)

21 CFR 820

21 U.S.C. 321(h)

21 U.S.C. 381(a)

21 CFR 820.198(a)

21 U.S.C. 351(h)

21 CFR 820.184

21 U.S.C. 360i

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Record Information

Company

Won Industry Co. LTD

Inspection Date

April 11, 2019

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: c6a3e437-b258-4ee3-af98-4c516e9f2e6e

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