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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Gramercy Fertility Services - Close Out Letter 8/3/12


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

Public Health Service
Food and Drug Administration

New York District
158-15 Liberty Avenue
Jamaica, NY 11433

August 3, 2012

Dr. Khaled Zeitoun, Medical Director
Carlo Acosta, Tissue Bank Director
Gramercy Fertility Services
139 E. 23rd St., 2nd Floor
New York, NY 10010-3794

Dear Dr. Zeitoun & Mr. Acosta:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to Warning Letter NYK-2012-20 issued to you on May 18, 2012. Based on our evaluation of your written responses and follow-up inspection, it appears that you have addressed the violations 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.



LCDR Frank Verni, USPHS
Compliance Officer
FDA- New York District