FDA WARNING_LETTER - Iradimed Corporation - April 16, 2014

FDA WARNING_LETTER for Iradimed Corporation on April 16, 2014. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Iradimed Corporation on April 16, 2014. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 820.25(b)

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

21 CFR 820.100(a)

21 CFR 820

21 U.S.C. 321(h)

21 U.S.C. 360(k)

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

21 U.S.C. 351(h)

21 U.S.C. 352(o)

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Record Information

Company

Iradimed Corporation

Inspection Date

April 16, 2014

Product Type

Devices

Office

Florida District Office

People

Elizabeth W. Ormond

ID: f2da1ab3-b4aa-42e3-ae60-cfc1b9c73aaa

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