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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Nurse Assist, Inc - Close Out Letter 8/17/2012

  

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

Public Health Service
Food and Drug Administration
 Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128

August 17, 2012


CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Kevin W. Kile, President and Chief Operating Officer
Nurse Assist, Inc.
3400 Northern Cross Blvd.
Fort Worth, Texas 76137


Dear Mr. Kile:


The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, 2012-DAL-WL-02, issued on October 21, 2011. 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 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/

Shari J. Shambaugh
Director, Compliance Branch
Dallas District Office

SJS/txt

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