FDA WARNING_LETTER - SEDECAL SA - January 24, 2025

FDA WARNING_LETTER for SEDECAL SA on January 24, 2025. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for SEDECAL SA on January 24, 2025. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 1020.30

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

21 CFR 820.100(a)

21 CFR 820

21 CFR 1020.31

21 U.S.C. 321(h)

21 CFR 1002.30(a)(1)

21 CFR 806.10

21 U.S.C. 351(h)

21 CFR 820.30(g)

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Record Information

Company

SEDECAL SA

Inspection Date

January 24, 2025

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: 1757da25-4869-4b06-be44-8b1fb0adb2f0

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