FDA WARNING_LETTER - General Hearing Instruments Inc - August 15, 2013

FDA WARNING_LETTER for General Hearing Instruments Inc on August 15, 2013. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for General Hearing Instruments Inc on August 15, 2013. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.22

21 CFR 820.30(a)

21 CFR 820.100(a)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.90(a)

21 CFR 820.198(a)

21 CFR 820.50

21 U.S.C. 351(h)

21 CFR 820.181

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Record Information

Company

General Hearing Instruments Inc

Inspection Date

August 15, 2013

Product Type

Devices

Office

New Orleans District Office

People

Patricia K. Schafer

ID: 3cd22b9c-e01d-4936-8cb0-ffe3d1a51bbb

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