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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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23andMe, Inc. - Close Out Letter 3/25/14

  

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

Food and Drug Administration
 10903 New Hampshire Avenue
Silver Spring, MD 20993

 

March 25, 2014


Mrs. Anne Wojcicki
Co-Founder & Chief Executive Officer
23andMe, Inc.
1390 SHOREBIRD WAY
MOUNTAIN VIEW, CA 94043


Dear Mrs. Wojcicki:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS 415534 dated November 22, 2013. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter.

Your firm's response to our Warning Letter appears to be adequate. 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/

Alberto Gutierrez
Office of In vitro Diagnostics and
     Radiological Health
Center for Devices and Radiological Health