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  5. Insulet Corporation - 03/02/2017
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Insulet Corporation

Insulet Corporation

United States

Issuing Office:

United States



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New England District Office (NWE-DO)
One Montvale Avenue, 4th floor
Stoneham, MA 02180
Phone 781.587.7500 


March 2, 2017

Mr. Patrick J. Sullivan
President and CEO
Insulet Corporation
600 Technology Park Drive
Suite 200
Billerica, MA 01821-4126

Dear Mr. Sullivan:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [CMS 460940, June 5, 2015]. Based on our evaluation, it appears that you have addressed the violation(s) 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.


Lori A. Holmquist
Acting District Director
New England District Office 

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