FDA EIR - Sekisui Medical Co., Ltd - October 17, 2019

FDA EIR for Sekisui Medical Co., Ltd on October 17, 2019. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA EIR for Sekisui Medical Co., Ltd on October 17, 2019. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.198

21 CFR 820.30

21 CFR 820.100(a)

21 CFR 820.90(a)

21 CFR 803

21 CFR 820.75(a)

21 CFR 820.50

21 CFR 820.184

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Record Information

Company

Sekisui Medical Co., Ltd

Inspection Date

October 17, 2019

Product Type

Devices

Office

Office of Medical Device and Radiological Health Operations

People

ID: 188b9524-7b9a-4668-a961-6cb6115963a1

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