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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Fertility and Reproductive Medicine Center for Women - Close Out Letter 9/29/10


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

Public Health Service
Food and Drug Administration
 555 Winderley PI., Ste. 200
Maitland, FI 32751

September 29, 2010

Diran Chamoun, M.D.
Owner and Medical Director
Fertility and Reproductive Medicine Center for Women
D/b/a: Viera Fertility Clinic
3160 Alzante Circle
Melbourne, FL 32940

Dear Dr. Chamoun:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter [FLA-10-11, January 26, 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.



Emma R Singleton
Director, Florida District