FDA WARNING_LETTER - Micro-X Ltd. - May 23, 2024

FDA WARNING_LETTER for Micro-X Ltd. on May 23, 2024. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Micro-X Ltd. on May 23, 2024. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 1020.30

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

21 CFR 820.100(a)

21 CFR 820.30(i)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 1010

21 CFR 1002.20

21 CFR 1020.30(h)(3)

21 CFR 1000-1005

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Record Information

Company

Micro-X Ltd.

Inspection Date

May 23, 2024

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: fb507b84-af84-4d78-bc5e-91ea41dfb7dc

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