FDA WARNING_LETTER - Soulaire Corporation - December 07, 2023

FDA WARNING_LETTER for Soulaire Corporation on December 07, 2023. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Soulaire Corporation on December 07, 2023. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

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

21 U.S.C. 321(h)

21 CFR 870.5225

21 U.S.C. 360(k)

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

21 CFR 807.81(b)

21 U.S.C. 352(o)

21 CFR 801.87(a)(3)(ii)

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Record Information

Company

Soulaire Corporation

Inspection Date

December 7, 2023

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Bram D. Zuckerman

ID: 9b213504-a05a-4e4b-b565-c33166d7bb75

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