FDA WARNING_LETTER - The Utopia Group LLC - March 27, 2014

FDA WARNING_LETTER for The Utopia Group LLC on March 27, 2014. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for The Utopia Group LLC on March 27, 2014. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.22

21 U.S.C. 352(t)(2)

21 CFR 820.30

21 CFR 820.25(b)

21 CFR 820.100(a)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.100(b)

21 CFR 820.90(a)

21 CFR 820.198(a)

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Record Information

Company

The Utopia Group LLC

Inspection Date

March 27, 2014

Product Type

Devices

Office

Cincinnati District Office

People

Paul J. Teitell (District Director)

ID: 22523f88-f7fd-4474-b222-c2816f6b7cb5

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