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U.S. Department of Health and Human Services

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Enforcement Actions

Genetics & IVF Institute - Close Out Letter 11/19/10

  

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

Public Health Service
Food and Drug Administration
 

10903 New Hampshire Avenue
Silver Spring, MD 20993

November 19, 2010


David Wise
CEO
Genetics & IVF Institute
3015 Williams Drive, 3rd Floor
Fairfax, VA 22031-4623

Dear Mr. Wise:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter dated November 10, 2009. Based on our evaluation, 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.

Sincerely,

/s/


Anne T. Hawthorn, J.D.
Chief
Special Investigation Branch
Division of Bioresearch Monitoring
Office of Compliance Center for Devices and
Radiological Health