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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Lancome - Close Out Letter 11/19/12

  

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

Public Health Service
Food and Drug Administration
 5100 Paint Branch Parkway
College Park, MD 20740

NOV 19 2012


Paul M. Hyman
Law Offices of Hyman, Phelps & McNamara, P.C.
700 Thirteenth Street, N.W.
Suite 1200
Washington, DC 20005


Re: 273596


Dear Mr. Hyman:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated September 7, 2012. Based on our review, it appears that you have addressed the violations contained in this Warning Letter. Future FDA assessments 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 (the 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 review of your web sites or through other means.


Sincerely,

/S/

Kathleen M. Lewis, J.D.
Team Leader
Labeling and Dietary Supplement
     Compliance Team
Center for Food Safety
       and Applied Nutrition


Cc:
Serge Jureidini
President
Lancome USA
575 Fifth Avenue
New York, NY 10017