FDA Inspection 783718 - SystemsOne, LLC - May 24, 2012

FDA Inspection 783718 for SystemsOne, LLC on May 24, 2012. Classification: Official Action Indicated (OAI).

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Record Summary

FDA Inspection 783718 for SystemsOne, LLC on May 24, 2012. Classification: Official Action Indicated (OAI).

Violation Codes

21 CFR 803.17(a)(1)

21 CFR 820.100(a)

21 CFR 820.181

21 CFR 820.184

21 CFR 820.198(a)

21 CFR 820.22

21 CFR 820.30(g)

21 CFR 820.30(i)

21 CFR 820.50

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Record Information

Company

SystemsOne, LLC

Inspection Date

May 24, 2012

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: f8632c6c-e0b2-4aa4-ba62-41e8a882949e

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