FDA WARNING_LETTER - Ortec - January 09, 2025

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

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Record Summary

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

Violation Codes

21 CFR 820.90

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

21 CFR 820.30(a)

21 CFR 820.100(a)

21 U.S.C. 321(h)

21 U.S.C. 381(a)

21 CFR 820.75(a)

21 CFR 820.50

21 U.S.C. 351(h)

21 CFR 820.70(g)

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Record Information

Company

Ortec

Inspection Date

January 9, 2025

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Courtney H. Lias (Acting Director)

ID: fdbe9275-1b80-47ff-b836-a85dd80bb793

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