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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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EndoGastric Solutions, Inc. - Close Out Letter 2/14/12

  

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

Public Health Service
Food and Drug Administration
 

Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421
Telephone: 425-486-8788
FAX: 425-483-4996

February 14, 2012

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Thierry B. Thaure, Chief Executive Officer
EndoGastric Solutions, Inc.
8210 154th Avenue Northeast
Redmond, Washington 98052

Dear Mr. Thaure:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 10-18, dated March 12, 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/

Charles M. Breen
District Director