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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Guidewire Technologies, Inc Close out letter

  

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

Public Health Service
Food and Drug Administration
 New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
(781) 596-7700
FAX: (781) 596-7896 

September 28, 2010
 

Mr. Douglas Curtis
President
Guidewire Technologies, Inc.
26 Keewaydin Drive
Salem, NH 03079

Dear Mr. Curtis:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter NWE-14-10W dated February 26, 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.
 

Sincerely,
/S/
Lori A. Holmquist
Compliance Officer
New England District Office
Augusta Maine Resident Post