FDA WARNING_LETTER - Taewoong Medical Co., Ltd. - July 31, 2014

FDA WARNING_LETTER for Taewoong Medical Co., Ltd. on July 31, 2014. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Taewoong Medical Co., Ltd. on July 31, 2014. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 803.50(a)(1)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.198(c)

21 CFR 803

21 CFR 820.75(a)

21 U.S.C. 351(h)

21 U.S.C. 360i

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Record Information

Company

Taewoong Medical Co., Ltd.

Inspection Date

July 31, 2014

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Steven D. Silverman (President)

ID: 7b000e6d-7c8d-4249-8840-c9993af1141c

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