Inspections, Compliance, Enforcement, and Criminal Investigations
23andMe, Inc. - Close Out Letter 3/25/14
Department 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
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.
Office of In vitro Diagnostics and
Center for Devices and Radiological Health