FDA WARNING_LETTER - Lexion Medical Llc - June 22, 2021

FDA WARNING_LETTER for Lexion Medical Llc on June 22, 2021. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Lexion Medical Llc on June 22, 2021. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 360j(g)

21 U.S.C. 331(a)

21 U.S.C. 331(k)

21 U.S.C. 352(a)

21 U.S.C. 351(f)(1)(B)

21 U.S.C. 321(h)

21 U.S.C. 360(k)

21 U.S.C. 360e(a)

21 CFR 801.6

21 U.S.C. 352(o)

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Record Information

Company

Lexion Medical Llc

Inspection Date

June 22, 2021

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: 4f5afdfd-760f-42a2-94b1-d649036fede0

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