FDA WARNING_LETTER - GPC Medical Ltd. - June 22, 2017

FDA WARNING_LETTER for GPC Medical Ltd. on June 22, 2017. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for GPC Medical Ltd. on June 22, 2017. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.80(d)

21 CFR 820.120

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.75(a)

21 U.S.C. 351(h)

21 CFR 820.184

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Record Information

Company

GPC Medical Ltd.

Inspection Date

June 22, 2017

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: e2ab7e15-0ff3-4821-8dc5-74a213e7d102

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