FDA WARNING_LETTER - InfuTronix LLC - February 15, 2022

FDA WARNING_LETTER for InfuTronix LLC on February 15, 2022. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for InfuTronix LLC on February 15, 2022. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 803.17(a)(1)

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

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

21 CFR 803.17(a)(3)

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

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.100(a)(1)

21 U.S.C. 360(k)

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

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Record Information

Company

InfuTronix LLC

Inspection Date

February 15, 2022

Product Type

Devices

Office

Office of Medical Devices and Radiological Health Operations Div. 1 East

People

ID: e5df945b-61ed-444f-980d-415f93daeb0f

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