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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

MDR Fitness Corporation - Close Out Letter 10/18/13

  

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

 
 Food and Drug Administration
Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751

Telephone: 407-475-4700
             FAX: 407-475-4770

 

October 18, 2013


Patricia A. Riley
Owner/President
MDR Fitness Corporation
14101 NW 4th Street
Sunrise, FL 33325


Dear Ms. Riley:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter [FLA-13-10, dated January 29, 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.

 

Sincerely,

/S/

Emma R. Singleton
Director, Florida District