FDA WARNING_LETTER - WISSNER-BOSSERHOFF GMBH - April 25, 2024

FDA WARNING_LETTER for WISSNER-BOSSERHOFF GMBH on April 25, 2024. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for WISSNER-BOSSERHOFF GMBH on April 25, 2024. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 806.20(b)(4)

21 CFR 820.50(a)

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

21 CFR 820.100(a)

21 CFR 820

21 CFR 820.72(a)

21 U.S.C. 321(h)

21 CFR 820.80(b)

21 CFR 820.30(d)

21 U.S.C. 351(h)

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Record Information

Company

WISSNER-BOSSERHOFF GMBH

Inspection Date

April 25, 2024

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Kellie B. Kelm

ID: 7d271309-eb8e-45da-812d-fcea50c13184

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