Inspections, Compliance, Enforcement, and Criminal Investigations

Intuitive Surgical, Inc. - Close Out Letter 4/25/14


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

 Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94501-7070
Telephone: (510) 337-6700


April 25, 2014

Gary S. Guthart, President and CEO
Intuitive Surgical, Inc.
1266 Kifer Road, Bldg 100
Sunnyvale, CA 94086-5304

Dear Mr. Guthart:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #406661. 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.




Lawton W. Lum
Director of Compliance

Page Last Updated: 04/24/2014
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