FDA WARNING_LETTER - FUJIFILM Healthcare Americas Corporation - May 01, 2015

FDA WARNING_LETTER for FUJIFILM Healthcare Americas Corporation on May 01, 2015. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for FUJIFILM Healthcare Americas Corporation on May 01, 2015. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 820.30

21 CFR 820.100(a)

21 CFR 820

21 CFR 820.72(a)

21 CFR 806.10(a)(1)

21 U.S.C. 321(h)

21 CFR 820.80(b)

21 CFR 820.70(a)

21 CFR 820.198(a)

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Record Information

Company

FUJIFILM Healthcare Americas Corporation

Inspection Date

May 1, 2015

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: e024b9ff-36ce-43ac-a32d-ca1daf1e1104

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