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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Medical Cosmetic Enhancements - 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

Dr. Drew Varano
Medical Cosmetic Enhancements
2 Wisconsin Circle, Suite 220
Chevy Chase, MD 20815

Dear Dr. Varano:

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: Evelyn Bonnin, District Director
Baltimore District Office, HFR-CE200
6000 Metro Drive, Suite 101
Baltimore, MD 21215


Randy Pack, Director Compliance Branch
Baltimore District Office, HFR-CE240
6000 Metro Drive, Suite 101
Baltimore, MD 21215