FDA WARNING_LETTER - I.T.S. GmbH - January 19, 2023

FDA WARNING_LETTER for I.T.S. GmbH on January 19, 2023. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for I.T.S. GmbH on January 19, 2023. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 803.20(c)(1)

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

21 CFR 803.18(b)(1)(i)

21 CFR 803.3

21 CFR 820.100(a)

21 CFR 803.50(a)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 803

21 U.S.C. 351(h)

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Record Information

Company

I.T.S. GmbH

Inspection Date

January 19, 2023

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: 58478b44-b734-4a69-9f46-af323495dd19

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