FDA WARNING_LETTER - Biomedix Wai - October 31, 2019

FDA WARNING_LETTER for Biomedix Wai on October 31, 2019. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Biomedix Wai on October 31, 2019. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.90

21 CFR 820.75(b)

21 CFR 820.80(c)

21 CFR 820.30(i)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.75(a)

21 U.S.C. 351(h)

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Record Information

Company

Biomedix Wai

Inspection Date

October 31, 2019

Product Type

Devices

Office

Office of Medical Device and Radiological Health Operations

People

ID: f35cb5bf-0dd2-4b7c-b939-d5e8bc85ffb4

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