FDA Inspection 780939 - Quanta System SpA - April 19, 2012

FDA Inspection 780939 for Quanta System SpA on April 19, 2012. Classification: Official Action Indicated (OAI).

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Record Summary

FDA Inspection 780939 for Quanta System SpA on April 19, 2012. Classification: Official Action Indicated (OAI).

Violation Codes

21 CFR 803.17(b)(1)

21 CFR 820.100(a)

21 CFR 820.100(b)

21 CFR 820.120(b)

21 CFR 820.198(a)

21 CFR 820.198(c)

21 CFR 820.200(b)

21 CFR 820.22

21 CFR 820.25(b)

21 CFR 820.250(b)

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Record Information

Company

Quanta System SpA

Inspection Date

April 19, 2012

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: fa56de90-ad80-4308-a46b-58682c6ea057

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