FDA Inspection 875526 - Iradimed Corporation - April 16, 2014

FDA Inspection 875526 for Iradimed Corporation on April 16, 2014. Classification: Official Action Indicated (OAI).

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Record Summary

FDA Inspection 875526 for Iradimed Corporation on April 16, 2014. Classification: Official Action Indicated (OAI).

Violation Codes

21 CFR 820.100(a)

21 CFR 820.198(e)

21 CFR 820.25(b)

21 CFR 820.30(c)

21 CFR 820.30(e)

21 CFR 820.30(g)

21 CFR 820.30(i)

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Record Information

Company

Iradimed Corporation

Inspection Date

April 16, 2014

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: f8216942-94e1-45f7-901d-49c762f3ab96

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