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Align Technology Inc

Align Technology Inc

United States

Issuing Office:

United States


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 94502-7070
Telephone: (510) 337-6700
FAX: (510) 337-6707

July 27, 2015

Mr. John Dangelo, Vice President
Align Technology, Inc.
2560 Orchard Parkway
San Jose, CA 95131-1033

Dear Mr. Dangelo:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter, dated November 17, 2010. 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.



Russell A. Campbell
Compliance Officer

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