FDA WARNING_LETTER - DFI Co., Ltd. - January 09, 2025

FDA WARNING_LETTER for DFI Co., Ltd. on January 09, 2025. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for DFI Co., Ltd. on January 09, 2025. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.90

21 CFR 803.20(c)(1)

21 CFR 820.120

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

21 CFR 820.120(a)

21 CFR 820.120(b)

21 CFR 803.50(a)

21 CFR 820.86

21 CFR 820

21 U.S.C. 321(h)

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Record Information

Company

DFI Co., Ltd.

Inspection Date

January 9, 2025

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: 40ce4d9a-91d4-4854-808d-5d6e6e44d4ac

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