FDA WARNING_LETTER - Global Medical Technology SL - October 10, 2019

FDA WARNING_LETTER for Global Medical Technology SL on October 10, 2019. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Global Medical Technology SL on October 10, 2019. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.22

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

21 CFR 820.30(a)

21 CFR 820.25(b)

21 CFR 820.100(a)

21 CFR 820

21 CFR 820.72(a)

21 U.S.C. 321(h)

21 CFR 820.80(b)

21 CFR 820.90(a)

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Record Information

Company

Global Medical Technology SL

Inspection Date

October 10, 2019

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: af308bc8-1fd9-4a4a-a3a7-0936924fead8

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