FDA WARNING_LETTER - Fresenius Kabi AG - September 07, 2023

FDA WARNING_LETTER for Fresenius Kabi AG on September 07, 2023. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Fresenius Kabi AG on September 07, 2023. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 803.17(a)(1)

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

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

21 CFR 820.30(a)

21 CFR 803.17(a)(3)

21 CFR 820.100(a)

21 CFR 820.30(i)

21 CFR 803.12(a)

21 CFR 820

21 U.S.C. 321(h)

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Record Information

Company

Fresenius Kabi AG

Inspection Date

September 7, 2023

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: 750541cb-7b33-41d1-9235-f10778aa024c

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