FDA WARNING_LETTER - Quality Electrodynamics LLC - March 09, 2015

FDA WARNING_LETTER for Quality Electrodynamics LLC on March 09, 2015. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Quality Electrodynamics LLC on March 09, 2015. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.100(a)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.90(b)(2)

21 CFR 820.70(a)

21 CFR 820.198(a)

21 CFR 820.75(a)

21 CFR 820.50

21 U.S.C. 351(h)

21 CFR 820.30(g)

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Record Information

Company

Quality Electrodynamics LLC

Inspection Date

March 9, 2015

Product Type

Devices

Office

Cincinnati District Office

People

Douglas T. Heitkemper (Director)

ID: c6cd886a-95cf-492e-bd62-ae14c970602e

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