FDA WARNING_LETTER - MANDELAY KFT - October 17, 2019

FDA WARNING_LETTER for MANDELAY KFT on October 17, 2019. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for MANDELAY KFT on October 17, 2019. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.30

21 CFR 820.120(b)

21 CFR 820

21 U.S.C. 321(h)

21 U.S.C. 381(a)

21 CFR 820.70(a)(1)

21 CFR 820.198(a)

21 U.S.C. 351(h)

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Record Information

Company

MANDELAY KFT

Inspection Date

October 17, 2019

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: 22c2bd07-9dea-444f-8e93-edc1a38fe9b5

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