FDA WARNING_LETTER - Otologics LLC - November 19, 2009

FDA WARNING_LETTER for Otologics LLC on November 19, 2009. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Otologics LLC on November 19, 2009. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 360j(g)

21 CFR 812.140(b)(1)

21 CFR 812.140(b)(2)

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Record Information

Company

Otologics LLC

Inspection Date

November 19, 2009

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Michael E. Marcarelli

ID: ddf621d0-98bb-4411-bd0d-2d8ae653fcd3

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