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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Tinnitus Control, Inc. - Close out Letter 5/10/10


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

Public Health Service
Food and Drug Administration
  10903 New Hampshire: Ave.
Silver Spring, MD 20993-0002

MAY 10 2010

Dr. Daniel S. J. Choy
Chairman & Medical Director
Tinnitus Control, Inc.
66 East 80th Street, Suite 1A
New York, NY 10021

Dear Dr. Choy:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter dated March 17, 2010. 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.


Timothy A. Ulatowski
Office of Compliance
Center for Devices and Radiological Health