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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Cardio Renew Inc - Close Out Letter 8/29/11

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 

Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7114
FAX: (612) 334-4142

August 29, 2011

Jay G. Hoogenakker
President
Cardio Renew, Inc.
1020 E. 146th Street, Suite 111
Burnsville, Minnesota 55337

Dear Mr. Hoogenakker:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter MIN 11-01, dated October 12, 2010. Based on our evaluation, it appears that you have addressed the violations 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 ensure 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.

Sincerely,

/s/

Tyra S. Wisecup
Compliance Officer
Minneapolis District
 

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