FDA WARNING_LETTER - Sekisui Medical Co., Ltd - June 12, 2014

FDA WARNING_LETTER for Sekisui Medical Co., Ltd on June 12, 2014. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Sekisui Medical Co., Ltd on June 12, 2014. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.100(a)

21 CFR 820.30(i)

21 CFR 820

21 CFR 820.72(a)

21 U.S.C. 321(h)

21 CFR 820.90(a)

21 CFR 820.20(c)

21 CFR 820.75(a)

21 U.S.C. 351(h)

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Record Information

Company

Sekisui Medical Co., Ltd

Inspection Date

June 12, 2014

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: f7bc52ab-7e74-4219-a006-7696ab422b93

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