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CLOSEOUT LETTER

Lifewatch Services, Inc.


Lifewatch Services, Inc.

  

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

 
 U.S. Food and Drug Administration
Chicago District Office
550 W. Jackson Blvd., 15th Floor
Chicago, IL 60661
Telephone: (312) 353-5863
Fax: (312) 596-4187
www.fda.gov

 

September 26, 2016

 

Mr. Roger K. Richardson
President
Lifewatch Services, Inc.
10255 W. Higgins Road
Rosemont, Illinois 60018

 

Dear Mr. Richardson:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CHI-5-13 dated December 17, 2012. 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/

William R. Weissinger
Director