FDA Inspection 1019051 - HUREV Co., Ltd. - June 29, 2017

FDA Inspection 1019051 for HUREV Co., Ltd. on June 29, 2017. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 1019051 for HUREV Co., Ltd. on June 29, 2017. Classification: Voluntary Action Indicated (VAI).

Violation Codes

21 CFR 820.100(a)

21 CFR 820.184

21 CFR 820.70(c)

21 CFR 820.70(f)

21 CFR 820.70(g)

21 CFR 820.75(b)

21 CFR 820.80(d)

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Record Information

Company

HUREV Co., Ltd.

Inspection Date

June 29, 2017

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: f6dc6bc0-5567-44f4-a535-1ba90865fd2f

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