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  5. King Systems Corp. dba Ambu, Inc. - 10/04/2017
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King Systems Corp. dba Ambu, Inc.

King Systems Corp. dba Ambu, Inc.

United States

Issuing Office:

United States



Black HHS-Blue FDA Logo


Chicago District Office
550 W. Jackson Blvd., Suite 1500
Chicago, IL 60661
Telephone: (312) 353-5863
Fax: (312) 596-4187 



Mr. Joseph M. Zachman
Vice President U.S. Operations
King Systems Corporation
15011 Herriman Boulevard
Noblesville, Indiana 46060-4253

Dear Mr. Zachman:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 2013-DET-24 dated September 30, 2013. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Michael K. Larson
Compliance Officer
Human and Animal Food Operations East 6
Detroit District

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