FDA WARNING_LETTER - Ohio Medical Corporation - November 26, 2024

FDA WARNING_LETTER for Ohio Medical Corporation on November 26, 2024. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Ohio Medical Corporation on November 26, 2024. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 803.17(a)(1)

21 CFR 803.3(w)(3)

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

21 CFR 820.30

21 CFR 820.100(a)

21 CFR 803.50(a)(1)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.90(b)(2)

21 CFR 820.90(a)

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Record Information

Company

Ohio Medical Corporation

Inspection Date

November 26, 2024

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: 27f389a7-fb2e-4897-9732-bb4a02103b0d

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