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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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All About You Medspa, LLC - Close Out Letter 5/21/10

   

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

 Public Health Service
Food and Drug Administration
  Silver Spring, MD 20993

May 21, 2010

 

Ms. Deborah A. West
All About You LLC
1417 Bear Street
Madison, IN 47250

Dear Ms. West:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter dated April 5, 2010. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA follow-up 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/
Michael M. Levy, Jr., Esq.
Director
Division of New Drugs & Labeling Compliance
Office of Compliance

Center for Drug Evaluation and Research

cc: Joann M. Givens, District Director
Detroit District Office, HFR-CE700
300 River Place, Suite 5900
Detroit, MI 48207

Steven Barber, Director Compliance Branch
Detroit District Office, HFR-CE740
300 River Place, Suite 5900
Detroit, MI 48207

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