FDA Inspection 840237 - Atrium Medical Corporation - October 01, 2013

FDA Inspection 840237 for Atrium Medical Corporation on October 01, 2013. Classification: Official Action Indicated (OAI).

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Record Summary

FDA Inspection 840237 for Atrium Medical Corporation on October 01, 2013. Classification: Official Action Indicated (OAI).

Violation Codes

21 CFR 803.50(a)(1)

21 CFR 820.100(a)

21 CFR 820.198(a)

21 CFR 820.70(c)

21 CFR 820.70(i)

21 CFR 820.75(a)

21 CFR 820.75(b)

21 CFR 820.80(d)

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Record Information

Company

Atrium Medical Corporation

Inspection Date

October 1, 2013

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: f817aa00-23ba-474e-9843-b1e37909aa64

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